COUGH AND SORE THROAT CHILDRENS- acetaminophen, dextromethorphan hbr suspension 
HyVee Inc

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.

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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 Carton Image
COUGH AND SORE THROAT  CHILDRENS
acetaminophen, dextromethorphan hbr suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARRAGEENAN (UNII: 5C69YCD2YJ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
Product Characteristics
ColorRED (opaque) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-023-261 in 1 CARTON08/27/201512/18/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/27/201512/18/2018
Labeler - HyVee Inc (006925671)

Revised: 10/2018
 
HyVee Inc