Label: CVS DAYTIME SEVERE COLD AND FLU RELIEF SOFTGELS- acetaminohpen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
- 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 December 7, 2020
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- Active ingredients (in each softgel)
- ■ temporarily relieves common cold/flu
symptoms: ■ nasal congestion ■ sinus
congestion & pressure ■ cough due to minor throat
& bronchial irritation ■ minor aches & pains
■ headache ■ fever ■ sore throat
■ reduces swelling of nasal passages ■ temporarily
restores freer breathing through the nose
■ promotes nasal and/or sinus drainage
■ helps loosen phlegm (mucus) and thin bronchial
secretions to rid the bronchial passageways of
bothersome mucus and make coughs more
- ■ temporarily relieves common cold/flu
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 softgels 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
Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:
- skin reddening
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
- 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
■ you get nervous,
dizzy or sleepless ■ pain, nasal congestion, or cough
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
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.
■ take only as directed
■ do not exceed 8 softgels per 24 hours
adults & children 12 years
2 softgels with water
every 4 hours
children 4 to under 12 years ask a doctor children under 4 years do not use
■ when using other Nighttime or Daytime products,
carefully read each label to ensure correct dosing
- Other information
- Inactive ingredients
Principal Display Panel
Compare to the active ingredients in Vick® DayQuil® Cold & Flu*
Severe Cold/Flu Relief
ACETAMINOPHEN - Pain reliever; fever reducer
DEXTROMETHORPHAN HBr - Cough Suppressant
PHENYLEPHRINE HCl - Nasal Decongestant
Headache, Fever, Sore throat, Minor aches
& pains, Cough, Chest congestion, Nasal/Sinus
congestion & Sinus pressure
THIS PRODUCT IS
PACKAGED IN A
PACKAGE. USE ONLY IF
BLISTERS ARE INTACT.
*This product is not
manufactured or distributed
by Procter & Gamble, owner
of the registered trademarks
Vicks® DayQuil® Severe Cold
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2019 CVS/pharmacy
INGREDIENTS AND APPEARANCE
CVS DAYTIME SEVERE COLD AND FLU RELIEF SOFTGELS
acetaminohpen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-545 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange (Light Orange) Score no score Shape CAPSULE (oblong shaped) Size 20mm Flavor Imprint Code 341 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-545-24 2 in 1 CARTON 06/05/2019 1 12 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 final part341 06/05/2019 Labeler - CVS Pharmacy (062312574) Registrant - Spirit Pharmaceuticals LLC (179621011) Establishment Name Address ID/FEI Business Operations MEDGEL PRIVATE LTD 677385498 manufacture(69842-545)