DAY-NIGHT COLD AND FLU- day-night cold flu 
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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634T TARGET DAY-NIGHT COLD AND FLU RELIEF 11693-947

DAY COLD AND FLU RELIEF

Active ingredients (in each SOFTGEL)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Inactive ingredients: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Purposes:

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

Pain Reliever-Fever Reducer

Cough Suppressant

Antihistamine

Nasal Decongestant

Nasal Congestion
Headache & Body Ache
Cough
Runny Nose
Sore Throat

Warnings

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

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic 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. 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.

NIGHT COD AND FLU RELIEF

Active ingredeints in each softgel

ACETAMINOPHEN 325 mg

Dextromethorphan Hydrobromide 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

Inactive ingredients: FD&C Blue #1,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, , sorbitol sorbitan solution, titanium dioxide

PURPOSE

Pain Reliever-Fever Reducer

Cough Suppressant

Antihistamine

/Nasal Decongestant

DOSAGE & ADMINISTRATION

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as

directed by a doctor.

· children under 12 years: do not use

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal and sinus congestion

· temporarily reduces fever

Warnings

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

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more aloholic drinks every day while using this product

l Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic 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. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

24 COMBO

DAY-NIGHT COLD AND FLU 
day-night cold flu kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-947
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-947-241 in 1 BLISTER PACK; Type 0: Not a Combination Product07/01/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 BLISTER PACK 16 
Part 1 of 2
NIGHT COLD AND FLU RELIEF 
acetaminophen, capsule, liquid filled
Product Information
Item Code (Source)NDC:11673-946
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize16mm
FlavorImprint Code 72
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-946-088 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2021
Part 2 of 2
DAY COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Item Code (Source)NDC:11673-945
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SHELLAC (UNII: 46N107B71O)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
GELATIN (UNII: 2G86QN327L)  
WATER (UNII: 059QF0KO0R)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize16mm
FlavorImprint Code 70
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-945-1616 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2021
Labeler - TARGET CORP (006961700)
Registrant - TIME CAP LABS INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LTD925822975manufacture(11673-947)

Revised: 12/2020
Document Id: b79edda9-0367-f652-e053-2995a90a6f6c
Set id: 9e01e8d0-31c6-c2c0-e053-2995a90a1f58
Version: 3
Effective Time: 20201229
 
TARGET CORP