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

COLD AND FLU DAYTIME SEVERE by

Drug Labeling and Warnings

COLD AND FLU DAYTIME SEVERE 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, Phenylephrine HCl,
Dextromethorphan HBr, Guaifenesin

INACTIVE INGREDIENT

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

PURPOSE:

• Minor aches and Pains, fever
• Nasal Congestion & Sinus Pressure
• Cough
• Chest Congestion

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-972
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	BULLET	Size	16mm
Flavor		Imprint Code	73
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-972-16	16 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/29/2020
2	NDC: 11673-972-24	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/18/2020

Labeler - TARGET CORP (006961700)

Registrant - TIME CAP LABS,INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LTD		925822975	manufacture(11673-972)