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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
QUALITY CHOICE (Chain Drug Marketing Association)
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Cough suppressant Nasal decongestant  - temporarily relieves: nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold - nasal and sinus congestion - cough due to minor throat and bronchial irritation as may occur with a cold
Authorization status:
OTC monograph final
Authorization number:
63868-369-04

TRIACTING DAYTIME COLD COUGH CHILDRENS- dextromethorphan hbr, phenylephrine

hcl syrup

QUALITY CHOICE (Chain Drug Marketing Association)

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.

----------

Drug Facts

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Phenylephrine HCL 2.5 mg

Purpos es

Cough suppressant

Nasal decongestant

Us es

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 give 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

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 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the Active Ingredients in Children's Triaminic® Day Time Cold & Cough

Children's Triacting Daytime

Cold and Cough

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCL

Nasal Decongestant

For Ages 4 to 11

Alcohol 0.14%

Cherry Flavor

FL OZ (mL)

*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 BOTTLE OR

UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.©

43157 W. 9 Mile Rd

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Package Label

QUALITY CHOICE Children's Triacting Daytime Cold & Coug h

TRIACTING DAYTIME COLD COUGH CHILDRENS

dextromethorphan hbr, phenylephrine hcl syrup

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 38 6 8 -36 9

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

5 mg

in 5 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

2.5 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

MALTITO L (UNII: D6 5DG142WK)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 38 6 8 -36 9 -

1 in 1 BOX

0 5/30 /20 14

1

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 5/30 /20 14

QUALITY CHOICE (Chain Drug Marketing Association)

Labeler -

QUALIT Y CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 4/2019

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