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cough and sore throat childrens

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL
Labeler: HyVee Inc
NDC Code: 42507-023

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.

Hy-Vee, Inc. Children’s Cough & Sore Throat Drug Facts

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Dextromethorphan HBr 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Uses
temporarily relieves:
minor aches and pains
headache
minor sore throat pain
cough due to minor throat and bronchial irritation as may occur with a cold
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

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.

Do not use
in a child under 4 years of age
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the child has
liver disease
chronic cough that lasts, or as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is
taking the blood thinning drug warfarin

When using this product
do not exceed recommended dosage

Stop use and ask a doctor if
pain or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions
this product does not contain directions or complete warnings for adult use
do not give more than directed (see Overdose warning)
shake well before using
may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.

Age

Dose

children under 4 years of age

do not use

children 4 to under 6 years of age

5 mL

children 6 to under 12 years of age

10 mL

Other information
each 5 mL contains: sodium 3 mg
contains no aspirin
store at 20-25°C (68-77°F). Protect from light.
close cap tightly

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C red #40, flavor, glycerin, high fructose corn syrup, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the Active Ingredients of Children’s Triaminic® Cough & Sore Throat

See New Warnings

For Ages 4 to Under 12 Years

Children’s

Cough & Sore Throat

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Suspension Liquid

Relieves:

Fever

Sore Throat

Cough

CHERRY FLAVOR

4 FL OZ (118 mL)

COUGH AND SORE THROAT  CHILDRENS
acetaminophen, dextromethorphan hbr suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-023
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARRAGEENAN 
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
CALCIUM SULFATE 
SODIUM PHOSPHATE, TRIBASIC 
Product Characteristics
ColorRED (opaque) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:42507-023-261 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/27/2015
Labeler - HyVee Inc (006925671)

Revised: 05/2016
 
HyVee Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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