NDC | 69842-546-12 |
Set ID | 6cb1d08b-e544-4084-b9ed-1e0d99a709c8 |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS Pharmacy,Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- ▪
- temporarily relieves these symptoms due to a cold or flu:
- ▪
- minor aches and pains
- ▪
- headache
- ▪
- sore throat
- ▪
- cough
- ▪
- nasal congestion
- ▪
- sinus congestion and pressure
- ▪
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
- ▪
- temporarily reduces fever
-
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- ▪
- more than 6 packets in 24 hours, which is the maximum daily amount for this product
- ▪
- with other drugs containing acetaminophen
- ▪
- 3 or more alcoholic drinks every day while using this product
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
- ▪
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- ▪
- 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 you have
- ▪
- liver disease
- ▪
- heart disease
- ▪
- high blood pressure
- ▪
- thyroid disease
- ▪
- diabetes
- ▪
- difficulty in urination due to enlargement of the prostate gland
- ▪
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- ▪
- cough with excessive phlegm (mucus)
Stop use and ask a doctor if
- ▪
- 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
- ▪
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- ▪
- nervousness, dizziness, or sleeplessness occurs
-
Directions
- ▪
- do not take more than the recommended dose
- ▪
- take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
- ▪
- adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- ▪
- children under 12 years: do not use
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- ▪
- more than 5 packets in 24 hours, which is the maximum daily amount for this product
- ▪
- with other drugs containing acetaminophen
- ▪
- 3 or more alcoholic drinks every day while using this product
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
- ▪
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- ▪
- 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 you have
- ▪
- liver disease
- ▪
- heart disease
- ▪
- high blood pressure
- ▪
- thyroid disease
- ▪
- diabetes
- ▪
- 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
Ask a doctor or pharmacist before use if you are
- ▪
- taking the blood thinning drug warfarin
- ▪
- taking sedatives or tranquilizers
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
Stop use and ask a doctor if
- ▪
- 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
- ▪
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- ▪
- nervousness, dizziness, or sleeplessness occurs
-
Directions
- ▪
- do not take more than the recommended dose
- ▪
- take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
- ▪
- adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- ▪
- children under 12 years: do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL-
Compare to Alka-Seltzer PLUS® Severe Cold +Flu Day and Night Active Ingredients*
DAYTIME
SEVERE COLD & FLU
Acetaminophen / Pain reliever-fever reducer
Dextromethorphan HBr / Cough suppressant
Guaifenesin / Expectorant
Phenylephrine HCl / Nasal decongestantRelieves:
• Nasal Congestion • Headache
• Sore Throat • Body Ache • Cough
• Mucus • Chest Congestion • FeverHoney Lemon Flavor
Naturally and Artificially Flavored
NIGHTTIME
Severe Cold & Flu
Acetaminophen / Pain reliever-fever reducer
Dextromethorphan HBr / Cough suppressant
Doxylamine succinate / Antihistamine
Phenylephrine HCl / Nasal decongestantRelieves:
• Nasal Congestion • Headache
• Sore Throat • Body Ache
• Cough • Runny Nose • FeverHoney Lemon Flavor
Naturally and Artificially Flavored
TAMPER EVIDENT: DO NOT USE IF INDIVIDUAL POUCH IS TORN OR OPEN
DO NOT TAKE THESE PRODUCTS AT THE SAME TIME
6 DAY PACKETS + 6 NIGHT PACKETS
12 TOTALDistributed by: CVS Pharmacy, Inc.
One CVS Drive Woonsocket, RI 02895
©2017 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Money Back Guarantee
*These products is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Alka-Seltzer plus® Severe Cold +Flu Day and Night.
-
INGREDIENTS AND APPEARANCE
SEVERE COLD PLUS FLU DAYTIME NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-546 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-546-12 1 in 1 CARTON; Type 0: Not a Combination Product 07/14/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CARTON 6 Part 2 1 CARTON 6 Part 1 of 2 SEVERE COLD PLUS FLU DAYTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride powder, for solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CITRATE (UNII: EE90ONI6FF) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 in 1 CARTON; 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 07/14/2017 Part 2 of 2 SEVERE COLD PLUS FLU NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride powder, for solutionProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CITRATE (UNII: EE90ONI6FF) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 in 1 CARTON; 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 07/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/14/2017 Labeler - CVS Pharmacy,Inc. (062312574)