MAXIMUM STRENGTH NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled

MAXIMUM STRENGTH NIGHTTIME COLD AND FLU by

Drug Labeling and Warnings

MAXIMUM STRENGTH NIGHTTIME COLD AND FLU by is a Otc medication manufactured, distributed, or labeled by TARGET CORP, TIME CAP LABS INC, MARKSANS PHARMA LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Acetaminophen 325 mg
• Dextromethorphan HBr 10 mg
• Doxylamine succinate 6.25 mg
• Phenylephrine HCl 5 mg

INACTIVE INGREDIENT

FD&C Blue No. 1, gelatin, glycerin,polyethylene glycol , povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution titanium dioxide,

PURPOSE

Purpose

• Pain reliever/Fever reducer
• Cough suppressant
• Antihistamine
• Nasal decongestant

INDICATIONS & USAGE

• temporarily relieves common cold/flu symptoms:

nasal congestion, cough, nasal congestion, minor aches and pains, sore throat, headache, runny nose and sneezing

• temporarily reduces fever
• controls cough to help you get to sleet

DOSAGE & ADMINISTRATION

Directions -Do not take more than directed (see Overdose warning)

• do not exceed more than 8 softgels in any 24 hr- period -
• adults & children 12 yrs & older: take 2 Softgels every 4 hrs
• children under 12 yrs of age - Do not use.

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.

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

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled

Product 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)