Label: DAY TIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 0904-5763-12, 0904-5763-44
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated June 6, 2013
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- Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mgClose
Pain reliever/fever reducer
- temporarily relieves common cold and flu symptoms:
- minor aches and pains
- sore throat
- nasal congestion
- cough due to minor throat and bronchial irritation
- temporarily relieves common cold and flu symptoms:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- nervousness, dizziness or sleeplessness occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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 can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in 24 hours
- 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 other Day Time or Night Time products, carefully read each label to ensure correct dosing
- Other information
- store at room temperature 15º-30ºC (59º-86ºF)
- avoid excessive heat
- Inactive ingredients
butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
*may contain this ingredientClose
- Questions or comments?
- Principal Display Panel
MULTI-SYMPTOM COLD/FLU RELIEF
ACETAMINOPHEN - ACHES/FEVER/SORE THROAT
DEXTROMETHORPHAN HBr - COUGH
PHENYLEPHRINE HCl - NASAL CONGESTION
ALCOHOL-FREE • ANTIHISTAMINE-FREE
†Compare to the active ingredients in Vicks® DayQuil® LiquiCaps®
†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® LiquiCaps®.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.Close
- Product Label
Major Day Time Cold/Flu Relief Softgel
- INGREDIENTS AND APPEARANCE
DAY TIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5763 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 BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 20mm Flavor Imprint Code P19;95A;36A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-5763-12 12 in 1 BLISTER PACK 2 NDC:0904-5763-44 16 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 03/25/2011 Labeler - Major Pharmaceuticals (191427277)