DAYTIME SEVERE COLD AND FLU RELIEF SOFTGELS- acetaminohpen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
Daytime Severe Cold and Flu Relief Softgels by
Drug Labeling and Warnings
Daytime Severe Cold and Flu Relief Softgels by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, Spirit Pharmaceuticals LLC, MEDGEL PRIVATE LTD. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each softgel)
- Purpose
-
Uses
- ■ 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
productive.
- ■ temporarily relieves common cold/flu
-
Warnings
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
- 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
- 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
- diabetes
- 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
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.
-
Directions
■ take only as directed
■ do not exceed 8 softgels per 24 hoursadults & children 12 years
& over2 softgels with water
every 4 hourschildren 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
- QUESTIONS
-
PRINCIPAL DISPLAY PANEL
Compare to the active ingredients in Vicks® DayQuil® Cold & Flu*
MAXIMUM STRENGTH
Daytime Softgels
Severe Cold/Flu Relief
ACETAMINOPHEN - Pain reliever; fever reducer
DEXTROMETHORPHAN HBr - Cough Suppressant
GUAIFENESIN- Expectorant
PHENYLEPHRINE HCl - Nasal Decongestant
Relieves:
Headache, Fever, Sore throat, Minor aches
& pains, Cough, Chest congestion, Nasal/Sinus
congestion & Sinus pressure
Non-drowsy
Alcohol free
Antihistamine free24 SOFTGELS
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks® DayQuil® Severe Cold & Flu
-
INGREDIENTS AND APPEARANCE
DAYTIME SEVERE COLD AND FLU RELIEF SOFTGELS
acetaminohpen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 49035-617 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: 49035-617-24 2 in 1 CARTON 01/14/2020 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 01/14/2020 Labeler - Wal-Mart Stores Inc (051957769) Registrant - Spirit Pharmaceuticals LLC (179621011) Establishment Name Address ID/FEI Business Operations MEDGEL PRIVATE LTD 677385498 manufacture(49035-617)
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