Label: MAXIMUM STRENGTH DAYTIME - NIGHTTIME COLD AND FLU COLD AND FLU- acetaminophen, dextromethorphan hbr,guaienesin, phenylephrine hcl,doxylamine succinate kit
- NDC Code(s): 11673-925-24
- 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
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- MAXIMUM STRENGTH DAYTIME COLD AND FLU DRUG FACTS
- ACTIVE INGREDIENT
-
INDICATIONS & USAGE
- temporarily relieves common cold/flu symptoms: nasal congestion,headache, cough, minor aches and pains, sore throat
- temoporarily reducces fever
- prootes nasal and/or sinus drainage
- helps ollsen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
-
WARNINGS
Warnings
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8sogtgelsThis 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.
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
-
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. (1800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- PURPOSE
- Maximum Strength Nighttime Cold and Flu Drug Facts
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
-
WARNINGS
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.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH DAYTIME - NIGHTTIME COLD AND FLU COLD AND FLU
acetaminophen, dextromethorphan hbr,guaienesin, phenylephrine hcl,doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-925 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-925-24 24 in 1 CARTON 07/07/2020 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 16 Part 2 1 BLISTER PACK 8 Part 1 of 2 MAXIMUM STRENGTH COLD AND FLU
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filledProduct Information Item Code (Source) NDC:11673-978 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) SHELLAC (UNII: 46N107B71O) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) Product Characteristics Color orange Score no score Shape CAPSULE Size 10mm Flavor Imprint Code 78 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 16 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 Part 2 of 2 MAXIMUM STRENGTH NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filledProduct Information Item Code (Source) NDC:11673-979 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) GELATIN (UNII: 2G86QN327L) SHELLAC (UNII: 46N107B71O) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color green Score no score Shape CAPSULE Size 24mm Flavor Imprint Code 72 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 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 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(11673-925)