NDC | 53942-506-28 |
Set ID | ce900e42-d0c8-408d-a1c3-3a9bef1c97ee |
Category | HUMAN OTC DRUG LABEL |
Packager | DeMoulas Market Basket |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART343 |
- Drug FactsActive Ingredients (in each 15 mL, 1 tablespoon)
- Purpose
- Keep out of reach of children
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product.
Allergy Alert: Acetaminophen may causesevere skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reactions occurs, stop and seek medical help right away.
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
Do not use
- 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.
-
Ask a doctor before use if you have
Ask a doctor or pharmacist
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
Ask a doctor or pharmacist before use
if the user is taking the blood thinning drug warfarin - When using this product
-
Stop use and ask a doctor if
- you get nervous, dizzy, or sleepless
- new symptoms occur
- fever gets worse or lasts more than 3 days
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
- If pregnant of breast-feeding
-
Overdose Warning
Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
-
Directions
Directions
- take only as recommended (see overdose warning)
- use dosage cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
age dose
adults and children 12 years and over 30 mL (2 TBSP) every 4 hours
children 6 years to under 12 years 15 mL (1 TBSP) every 4 hours
children 4 years to under 6 years ask a doctor
children under 4 years do not use- When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
- Other information
- Inactive ingredients
- Questions?
-
Product Label
MARKET BASKET ®
“MORE FOR YOUR DOLLAR”
*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®
DAYQUIL ®DAY-TIME
COLD AND FLU RELIEFAcetaminophen……Pain Reliever/Fever Reducer
Dextromethorphan HBr……Cough Suppressant
Phenylephrine HCL ……. Nasal Decongestant12 FL OZ (354 ML)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences*This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark Vicks® Dayquil®.
DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.
875 EAST STREET
TEWKSBURY, MA 01876LR-036
LOT: EXP:
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INGREDIENTS AND APPEARANCE
DAY-TIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-506 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53942-506-28 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/12/2012 Labeler - DeMoulas Market Basket (007869647) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(53942-506)