NDC | 0280-1400-12, 0280-1400-20, 0280-1400-32, 0280-1400-36, 0280-1400-48, 0280-1400-72 |
Set ID | 78537dcf-b157-4b67-a8b2-5cb144815166 |
Category | HUMAN OTC DRUG LABEL |
Packager | Bayer HealthCare LLC. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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.
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
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
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for
- gout
- diabetes
- arthritis
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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 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 a loss of hearing occurs
- nervousness, dizziness, or sleeplessness occurs
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 36 Tablet Carton
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INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL
aspirin, chlorpheniramine maleate, and phenylephrine bitartrate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1400 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) CALCIUM SILICATE (UNII: S4255P4G5M) DIMETHICONE (UNII: 92RU3N3Y1O) DOCUSATE SODIUM (UNII: F05Q2T2JA0) MANNITOL (UNII: 3OWL53L36A) POVIDONES (UNII: FZ989GH94E) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor Imprint Code ALKA;SELTZER;PLUS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-1400-12 6 in 1 CARTON 04/10/2008 09/01/2011 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0280-1400-20 10 in 1 CARTON 04/10/2008 06/01/2019 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:0280-1400-32 16 in 1 CARTON 04/10/2008 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:0280-1400-36 18 in 1 CARTON 04/10/2008 06/01/2019 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:0280-1400-48 24 in 1 CARTON 06/10/2008 06/01/2019 5 2 in 1 POUCH; Type 0: Not a Combination Product 6 NDC:0280-1400-72 36 in 1 CARTON 04/10/2008 12/01/2019 6 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 not final part343 04/10/2008 Labeler - Bayer HealthCare LLC. (112117283)