COLD AND FLU DAYTIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Cold and Flu by
Drug Labeling and Warnings
Cold and Flu by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association). Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each softgel)
- Purposes
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen I 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
Allery alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use 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
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if the user has
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- nervousness, dizziness, or sleeplessness occur
- 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.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
-
Directions
- do not take more than directed (see overdose warning)
- do not take more than 4 doses in 24-hour period
- adults and children 12 years and over: take 2 softgels with water every 4 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 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 or comments?
-
Principal Display Panel
†Compare to the Active Ingredients in VICKS® DAYQUIL® COLD & FLU LIQUICAPS®
Non-Drowsy
Day Time
Multi-Symptom Relief For Cold/Flu
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Pain Reliever | Fever Reducer
Cough Suppressant | Nasal Decongestant
Non-Drowsy | Alcohol Free | Antihistamine Free
Softgels
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OR TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® DayQuil® and LiquiCaps® are registered trademarks of The Procter & Gamble Company.
Distributed by C.D.M.A., Inc©
43157 W 9 Mile Rd
Novi, MI 48375
- Package Label
-
INGREDIENTS AND APPEARANCE
COLD AND FLU DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 63868-736 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SORBITOL (UNII: 506T60A25R) POVIDONE (UNII: FZ989GH94E) SORBITAN (UNII: 6O92ICV9RU) LIGHT MINERAL OIL (UNII: N6K5787QVP) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color orange Score no score Shape OVAL Size 20mm Flavor Imprint Code PC9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 63868-736-24 24 in 1 CARTON 04/30/2021 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/30/2021 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.