Triacting Daytime Cold Cough Childrens: Package Insert and Label Information

TRIACTING DAYTIME COLD COUGH CHILDRENS- dextromethorphan hydrobromide and phenylephrine hydrochloride syrup
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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.

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 OLD EAST MAIN CO

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Package Label

DOLLAR GENERAL HEALTH Children’s Triacting Syrup Cherry Flavor

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM ALCOHOL BENZOIC ACID ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 MALTITOL PROPYLENE GLYCOL WATER SODIUM CITRATE

Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55910-378-04 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC 1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (55910-378-04)

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)

Revised: 02/2021 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)