MAXIMUM STRENGTH DAYTIME - NIGHTTIME COLD AND FLU COLD AND FLU- acetaminophen, dextromethorphan hbr,guaienesin, phenylephrine hcl,doxylamine succinate 
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 MAX STRENGTH COLD AND FLU DAYTIME-NIGHTTIME 11673-925

MAXIMUM STRENGTH DAYTIME COLD AND FLU
DRUG FACTS

Active ingredients (in each softgel)

ACETAMINOPHEN 325MG

DEXTROMETHORHAN HBR10 MG,

GUAIFENESIN 200 MG

, PHENYLEPHRINE HCL 5 MG

  • 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
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8sogtgels

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.

FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide

Do not take more than directed (See Overdose warning section) - do not exceed 12 Softgels per 24 hr period

  • adults & children 12 yrs & over 2 Softgels every 4 hrs
  • children 4 to under 12 yrs: Do not use

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.

PAIN RELIEVER-FEVER REDUCER

COUGH SUPPRESENT

MINOR ACHES AND PAINS

CHEST CONGESTION

Maximum Strength Nighttime Cold and Flu Drug Facts


(in each softgel)
Acetaminophen 325mg

Dextromethorphan HBR 10 mg

Doxylamine Succinate 6.25 mg

PhenylephrineHCl 5mg

Purpose

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

MINOR ACHES AND PAINS, FEVER

NASAL CONGESTION AND SINUS PRESSURE

SNEEZING, RUNNY NOSE

COUGH

PAIN RELIEVER-FEVER REDUCER

COUGH SUPPRESENT

MINOR ACHES AND PAINS

NASAL DECONGESTION

Warnings
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take

Allergy Alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

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.

Directions
take only as directed - do not exceed 8 softgels per 24 hours -

adults & children 12 yrs & over 2 softgels with water every 6 hrs -

children 4 to under 12 yrs ask a doctor -

children under 4 yrs do not use

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

Keep out of reach of children.

Overdose warning

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

24 COMBO

MAXIMUM STRENGTH DAYTIME - NIGHTTIME COLD AND FLU COLD AND FLU 
acetaminophen, dextromethorphan hbr,guaienesin, phenylephrine hcl,doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-925
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-925-2424 in 1 CARTON07/07/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 16 
Part 21 BLISTER PACK 8 
Part 1 of 2
MAXIMUM STRENGTH COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
Product Information
Item Code (Source)NDC:11673-978
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColororangeScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code 78
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/07/2020
Part 2 of 2
MAXIMUM STRENGTH NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled
Product Information
Item Code (Source)NDC:11673-979
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorgreenScoreno score
ShapeCAPSULESize24mm
FlavorImprint Code 72
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/07/2020
Labeler - TARGET CORP (006961700)
Registrant - TIME CAP LABS INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LTD925822975manufacture(11673-925)

Revised: 7/2020
Document Id: a9dd0199-03a5-885a-e053-2a95a90a2195
Set id: 9dff3771-c4c2-bd63-e053-2995a90acfd8
Version: 2
Effective Time: 20200707
 
TARGET CORP