Label: MAXIMUM STRENGTH NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled
- NDC Code(s): 11673-979-08
- Packager: TARGET CORP
- 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.
Drug Label Information
Updated July 7, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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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 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy Alert:
acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddening
- Blisters
- Rash
Sore troat 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.
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KEEP OUT OF REACH OF CHILDREN
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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-979 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 DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape CAPSULE (CAPSULE SHAPED) Size 24mm Flavor Imprint Code 72 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-979-08 8 in 1 BOX; Type 0: Not a Combination Product 07/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/13/2020 Labeler - TARGET CORP (006961700) Registrant - TIME CAP LABS INC (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LTD 925822975 manufacture(11673-979)
