DAYTIME COLD AND FLU MULTI SYMPTOM capsule, liquid filled

DAYTIME COLD AND FLU MULTI SYMPTOM by

Drug Labeling and Warnings

DAYTIME COLD AND FLU MULTI SYMPTOM 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

Active ingredients (In each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

INACTIVE INGREDIENT

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

PURPOSE

Pain reliever/fever reducer, cough suppressant, Nasal Decongestant

INDICATIONS & USAGE

temporarily relieves common cold/flu symptoms:

• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever

DOSAGE & ADMINISTRATION

• Directions:
  • take only as directed
  • do not exceed4 doses per 24 hours
• adults and children 12 yrs & over: 2 softgels with water every 4 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

KEEP OUT OF REACH OF CHILDREN

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 & 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 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAYTIME COLD AND FLU MULTI SYMPTOM 
daytime cold and flu multi symptom capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-975
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
SHELLAC (UNII: 46N107B71O)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	70
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-975-24	2 in 1 CARTON	07/07/2020
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/07/2020

Labeler - TARGET CORP (006961700)

Registrant - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LTD		925822975	manufacture(11673-975)