COLD AND FLU DAYTIME SEVERE- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled 
TARGET CORP

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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TARGET DAYTIME COLD AND FLU SEVERE 11673-972

Active ingredients(in each softgel)

Acetaminophen, Phenylephrine HCl,
Dextromethorphan HBr, Guaifenesin

Inactive Ingredients

polyethylene glycol 400, propylene glycol,povidone, shellac, titanium dioxide, gelatin, glycerin, soritol sorbitan solution, FD&C Blue no. 01, FD&C Red No. 40, Prified water

PURPOSE:

Uses
temporarily relieves common cold/flu symptoms: nasal congestion - sinus congestion & pressure - cough due to minor throat & bronchial irritation - minor aches & pains - headache - fever - sore throat - reduces ...

temporarily relieves common cold/flu symptoms:

nasal congestion
sinus congestion & pressure
cough due to minor throat & bronchial irritation
minor aches & pains
headache
fever
sore throat
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
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

Directions
take only as directed - do not exceed 8 LiquiCaps per 24 hrs - adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs - children 4 to under 12 yrs ask a doctor ...

take only as directed
do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over 2 softgelswith water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

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 ...

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.

Keep out of reach of children.

Overdose warning

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

24 count

COLD AND FLU DAYTIME SEVERE 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-972
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColororangeScoreno score
ShapeBULLETSize16mm
FlavorImprint Code 73
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-972-1616 in 1 BLISTER PACK; Type 0: Not a Combination Product05/29/2020
2NDC:11673-972-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product05/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/18/2020
Labeler - TARGET CORP (006961700)
Registrant - TIME CAP LABS,INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LTD925822975manufacture(11673-972)

Revised: 5/2020
Document Id: a5b5b448-9752-fbe7-e053-2a95a90a1e68
Set id: 9de99931-31ef-79e2-e053-2a95a90a98ad
Version: 2
Effective Time: 20200515
 
TARGET CORP