Label: DAYTIME COLD AND FLU MULTI SYMPTOM capsule, liquid filled
- NDC Code(s): 11673-975-24
- Packager: TARGET CORP
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 11, 2023
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Liver warning
This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 8 softgels in 24 hrs, 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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU MULTI SYMPTOM
daytime cold and flu multi symptom capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-975 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITOL (UNII: 506T60A25R) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) SHELLAC (UNII: 46N107B71O) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color orange Score no score Shape CAPSULE Size 20mm Flavor Imprint Code 70 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-975-24 2 in 1 CARTON 07/07/2020 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 07/07/2020 Labeler - TARGET CORP (006961700) Registrant - TIME CAP LABS INC (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LTD 925822975 manufacture(11673-975)