ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL- acetaminophen, dextromethorphan hbr, guailfenesin,phenlyephrine hcl capsule, liquid filled 
Kroger Company

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.

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628TKROGER 41226-628

Active ingredients (in each softgel)

acetamnophen 325 mg - Dextromethorphan HBr 10mg - Gualifenesin 200 mg - Phenylephrine HCl 5 mg

INACTIVE INGREDIENTS
Inactive ingredients: FD&C yellow#6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

PURPOSE

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

INDICATIONS & USAGE
temporarily relieves these common cold and flu symptoms: nasal congestion - headache - cough - minor aches and pains - sore throat - temporarily reduces fever - promotes nasal and/or sinus drainage - helps ...

temporarily relieves these common cold and flu symptoms:
nasal congestion
headache
cough
minor aches and pains
sore throat

temporarily reduces fever
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

DOSAGE & ADMINISTRATION

Directions
Do not take more than directed (see Overdose warning) do not take more than 12 SOFTGELS in any 24-hour period \

adults and children 12 years of age and over: take 2 SOFTGELS every 4 hours
children under 12 years of age: do not use

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 ...

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.

Warnings
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take: more than 12softgels in 24 hours, which is the maximum daily amount - with other drugs ...

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 12 softgels in 24 hours, which is the maximum daily amount
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

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.

16 COUNT

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL 
acetaminophen, dextromethorphan hbr, guailfenesin,phenlyephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-628
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code 78
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-628-1616 in 1 BLISTER PACK; Type 0: Not a Combination Product12/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/21/2020
Labeler - Kroger Company (006999528)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
marksans pharma ltd925822975manufacture(41226-628)

Revised: 12/2020
Document Id: b6bc9701-6bd5-f19c-e053-2995a90a81f4
Set id: a24f09d9-60f1-853a-e053-2a95a90ae1fa
Version: 3
Effective Time: 20201218
 
Kroger Company