NDC | 0280-1550-20 |
Set ID | 75894849-a0ba-57be-e053-2a91aa0a049a |
Category | HUMAN OTC DRUG LABEL |
Packager | Bayer HealthCare LLC. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each tablet)
Aspirin 325 mg (NSAID)*
Dextromethorphan hydrobromide 10 mg
Phenylephrine bitartrate 7.8 mg
*nonsteroidal anti-inflammatory drug
Close - PURPOSE
- INDICATIONS & USAGE
Uses
•temporarily relieves these symptoms due to a cold with cough:
• minor aches and pains • headache • cough
• nasal and sinus congestion • sore throat
• temporarily reduces fever
Close - WARNINGS
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from
chicken pox or flu-like symptoms should not use this product. When using this
product, if changes in behavior with nausea and vomiting occur, consult a
doctor because these symptoms could be an early sign of Reye’s syndrome, a
rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
● hives ● facial swelling ● asthma (wheezing) ● shock
Stomach bleeding warning: This product contains an NSAID, which may
cause severe stomach bleeding. The chance is higher if you
● are age 60 or older
● have had stomach ulcers or bleeding problems
● take a blood thinning (anticoagulant) or steroid drug
● take other drugs containing prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen, or others)
● have 3 or more alcoholic drinks every day while using this product
● take more or for a longer time than directed
Sore throat warning: If sore throat is severe, persists for more than 2 days,
is accompanied or followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.
Close - DO NOT USE
Do not use
● if you are allergic to aspirin or any other pain reliever/fever reducer
● if you are now taking a prescription monoamine oxidase inhibitor (MAOI)
(certain drugs for depression, psychiatric, or emotional conditions, or
Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you
do not know if your prescription drug contains an MAOI, ask a doctor or
pharmacist before taking this product.
● if you have ever had an allergic reaction to this product or any of its
ingredients
● in children under 12 years of age
Close - ASK DOCTOR
Ask a doctor before use if
● stomach bleeding warning applies to you
● you have a history of stomach problems, such as heartburn
● you have high blood pressure, heart disease, liver cirrhosis, or kidney
disease
● you are taking a diuretic
● you have
● asthma ● thyroid disease ● diabetes
● cough with excessive phlegm (mucus)
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● a sodium-restricted diet
Close - ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are
● taking a prescription drug for
● gout ● diabetes ● arthritis
Close - WHEN USING
- STOP USE
Stop use and ask a doctor if
● an allergic reaction occurs. Seek medical help right away.
● you experience any of the following signs of stomach bleeding
● feel faint ● vomit blood ● have bloody or black stools
● have stomach pain that does not get better
● pain, cough, or nasal congestion gets worse or lasts more than 7 days
● fever gets worse or lasts more than 3 days
● redness or swelling is present
● new symptoms occur
● ringing in the ears or loss of hearing occurs
● cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
● nervousness, dizziness, or sleeplessness occurs
Close - PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3
months of pregnancy unless definitely directed to do so by a
doctor because it may cause problems in the unborn child or
complications during delivery.
Close - KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away.
Close - Directions
Directions
● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.
● children under 12 years: do not use
Close - Other information
Other information
● each tablet contains: sodium 416 mg
● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet
● store at room temperature. Avoid excessive heat
Close - INACTIVE INGREDIENT
Inactive ingredients acesulfame potassium, anhydrous citric
acid, aspartame, calcium silicate, dimethicone, docusate sodium,
flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate
Close - QUESTIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each tablet)
Aspirin 500 mg (NSAID)*
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine bitartrate 7.8 mg
*nonsteroidal anti-inflammatory drug
Close - PURPOSE
- Uses
Uses
• temporarily relieves these symptoms due to a cold:
• minor aches and pains • headache • runny nose
• sinus congestion and pressure • cough • sneezing
• sore throat • nasal congestion
• temporarily reduces fever
Close - WARNINGS
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering
from chicken pox or flu-like symptoms should not use this product. When
using this product, if changes in behavior with nausea and vomiting occur,
consult a doctor because these symptoms could be an early sign of Reye’s
syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may
include:
● hives ● facial swelling ● asthma (wheezing) ● shock
Stomach bleeding warning: This product contains an NSAID, which may
cause severe stomach bleeding. The chance is higher if you
● are age 60 or older
● have had stomach ulcers or bleeding problems
● take a blood thinning (anticoagulant) or steroid drug
● take other drugs containing prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen, or others)
● have 3 or more alcoholic drinks every day while using this product
● take more or for a longer time than directed
Sore throat warning: If sore throat is severe, persists for more than
2 days, is accompanied or followed by fever, headache, rash, nausea,
or vomiting, consult a doctor promptly.
Do not use to sedate children.
Close - DO NOT USE
Do not use
● if you are allergic to aspirin or any other pain reliever/fever reducer
● if you are now taking a prescription monoamine oxidase inhibitor
(MAOI) (certain drugs for depression, psychiatric, or emotional
conditions, or Parkinson's disease), or for 2 weeks after stopping
the MAOI drug. If you do not know if your prescription drug contains
an MAOI, ask a doctor or pharmacist before taking this product.
● if you have ever had an allergic reaction to this product or any of its
ingredients
● in children under 12 years of age
Close - ASK DOCTOR
Ask a doctor before use if
● stomach bleeding warning applies to you
● you have a history of stomach problems, such as heartburn
● you have high blood pressure, heart disease, liver cirrhosis, or
kidney disease
● you are taking a diuretic
● you have
● asthma ● diabetes ● thyroid disease ● glaucoma
● cough with excessive phlegm (mucus)
● a breathing problem such as emphysema or chronic bronchitis
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● a sodium-restricted diet
Close - ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
• gout • diabetes • arthritis
• taking sedatives or tranquilizers
Close - WHEN USING
When using this product
● do not exceed recommended dosage
may cause marked drowsiness
● avoid alcoholic drinks
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
● excitability may occur, especially in children
Close - STOP USE
Stop use and ask a doctor if
● an allergic reaction occurs. Seek medical help right away.
● you experience any of the following signs of stomach bleeding
● feel faint ● vomit blood ● have bloody or black stools
● have stomach pain that does not get better
● pain, cough, or nasal congestion gets worse or lasts more than 7 days
● fever gets worse or lasts more than 3 days
● redness or swelling is present
● new symptoms occur
● ringing in the ears or loss of hearing occurs
● cough comes back or occurs with rash or headache that lasts. These
could be signs of a serious condition.
● nervousness, dizziness, or sleeplessness occurs
Close - PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3
months of pregnancy unless definitely directed to do so by a
doctor because it may cause problems in the unborn child or
complications during delivery.
Close - KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away.
Close - Directions
Directions
● adults and children 12 years and over: take 2 tablets fully dissolved
in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not
exceed 8 tablets in 24 hours or as directed by a doctor.
● children under 12 years: do not use
Close - Other information
Other information
● each tablet contains: sodium 476 mg
● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet
● store at room temperature. Avoid excessive heat.
Close - INACTIVE INGREDIENT
Inactive ingredients acesulfame potassium, anhydrous citric
acid, aspartame, calcium silicate, dimethicone, docusate sodium,
flavors (natural & artificial), mannitol, povidone, sodium benzoate,
sodium bicarbonate
Close - Questions or comments?
- Package Display Label
Alka-Seltzer
PLUS®
DAY NON-DROWSY
ASPIRIN (NSAID) / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Phenylephrine Bitartrate / Nasal Decongestant
- Nasal Congestion
- Headache & Body Ache
- Cough
- Sore Throat
- Sinus Pressure
12 EFFERVESCENT TABLETS
NIGHT
ASPIRIN (NSAID) / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Doxylamine Succinate / Antihistamine
Phenylephrine Bitartrate / Nasal Decongestant
- Nasal Congestion
- Headache & Body Ache
- Cough
- Runny nose
- Sore Throat
8 EFFERVESCENT TABLETS
- INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS COLD DAY AND NIGHT
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1550 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-1550-20 1 in 1 CARTON; Type 0: Not a Combination Product 09/14/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 POUCH 12 Part 2 4 POUCH 8 Part 1 of 2 ALKA-SELTZER PLUS COLD DAY
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescentProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength CALCIUM SILICATE (UNII: S4255P4G5M) SODIUM BENZOATE (UNII: OJ245FE5EU) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) DOCUSATE SODIUM (UNII: F05Q2T2JA0) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ASP;DAY Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 in 1 CARTON 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/14/2018 Part 2 of 2 ALKA-SELTZER PLUS COLD NIGHT
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate tablet, effervescentProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DOCUSATE SODIUM (UNII: F05Q2T2JA0) POVIDONE (UNII: FZ989GH94E) SODIUM BENZOATE (UNII: OJ245FE5EU) MANNITOL (UNII: 3OWL53L36A) DIMETHICONE (UNII: 92RU3N3Y1O) ASPARTAME (UNII: Z0H242BBR1) CALCIUM SILICATE (UNII: S4255P4G5M) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor LEMON Imprint Code ASP;NT Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 in 1 CARTON 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/14/2018 Labeler - Bayer HealthCare LLC. (112117283)