TRIACTING DAYTIME COLD COUGH CHILDRENS- dextromethorphan hbr, phenylephrine hcl syrup

Triacting Daytime Cold Cough by

Drug Labeling and Warnings

Triacting Daytime Cold Cough by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Cough suppressant

Nasal decongestant 

Uses

• temporarily relieves:
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Do not use

• in a child under 4 years of age
• in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• heart disease 
• high blood pressure
• thyroid disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• chronic cough that lasts, or as occurs with asthma

When using this product,

do not exceed recommended dosage.

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occurs
• symptoms do not improve within 7 days or occur with a fever
• cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device
• keep dosing cup with product
• mL = milliliter
• shake well before using

• age: dose
• children 6 to under 12 years of age: 10 mL every 4 hours
• children 4 to under 6 years of age: 5 mL every 4 hours
• children under 4 years of age: do not use

Other information

• each 5 mL contains: sodium 2 mg
• store between 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium citrate

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredients of children's Triaminic® DayTime Cold & Cough*

For Ages 4 to 11 years

Children's

Triacting

Syrup

Cough Suppressant (Dextromethorphan HBr)

Nasal Decongestant (Phenylephrine HCl)

Day Time Cold & Cough

Alcohol 0.14%

Relieves Cough and Stuffy Nose

Cherry Flavor

FL OZ (mL)

Dosing Cup Included

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Day Time Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

Package Label

DOLLAR GENERAL HEALTH Children's Day Time Cold & Cough

INGREDIENTS AND APPEARANCE

TRIACTING DAYTIME COLD COUGH  CHILDRENS
dextromethorphan hbr, phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-378
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-378-04	1 in 1 BOX	05/30/2014
1		118 mL in 1 BOTTLE, PLASTIC; 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	05/30/2014

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)