TRIACTING DAY TIME COLD AND COUGH CHILDRENS- dextromethorphan hbr, phenylephrine hcl liquid

Triacting Day Time Cold and Cough by

Drug Labeling and Warnings

Triacting Day Time Cold and Cough by is a Otc medication manufactured, distributed, or labeled by Care One (American Sales Company). 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

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

When using this product,

do not use more than directed.

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 5 years: 5 mL every 4 hours
• children under 4 years: do not use

Other information

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

Inactive ingredients

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

Questions or comments?

Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

For Ages 4 to 11

Children's Triacting Day Time Cold and Cough

Dextromethorphan HBr -Cough suppressant

Phenylephrine HCl-Nasal decongestant

Compare to active ingredients in Triaminic® DayTime Cold & Cough*

Relieves:

• Stuffy nose
• Cough

Cherry Flavor

FL OZ (mL)

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributors of Children's Triaminic® DayTime Cold & Cough.

DISTRIBUTED BY

FOODHOLD USA, LLC

LANDOVER, MD 20785

1-877-846-9949

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

Package Label

Care One Children's Triacting Day Time Cold and Cough

INGREDIENTS AND APPEARANCE

TRIACTING DAY TIME COLD AND COUGH  CHILDRENS
dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-378
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)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-378-04	1 in 1 BOX	06/30/2015
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	06/30/2015

Labeler - Care One (American Sales Company) (809183973)