COUGH AND SORE THROAT CHILDRENS PAIN RELIEF - acetaminophen and dextromethorphan hydrobromide 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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Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Dextromethorphan HBr 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Uses

Warnings

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

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 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if your child has

  • liver disease
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your 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.

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

Directions

Weight(lb)Age(yr)Dose (tsp or mL)
under 36 under 4 yearsdo not use
36-47 4 to 5 years1 tsp or 5 mL
48-956 to 11 years2 tsp or 10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

Inactive ingredients

carrageenan, citric acid, D&C red no. 33, edetate disodium, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, polysorbate 80, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children’s Tylenol® Plus Cough & Sore Throat active ingredients

Children’s Pain Relief

Cough & Sore Throat

Fever Reducer, Pain Reliever, Cough Suppressant

Plus

Contains 2 Ingredients:

Fever & Sore Throat

Acetaminophen

Cough

Dextromethorphan HBr

See New Warnings Information

Cherry Flavor

Oral Suspension

Cough and Sore Throat Carton Image 1

Cough and Sore Throat Carton Image 1

Cough and Sore Throat Carton Image 2

Cough and Sore Throat Carton Image 2


COUGH AND SORE THROAT  CHILDRENS PAIN RELIEF
acetaminophen, dextromethorphan hbr suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-196
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 
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 
CITRIC ACID MONOHYDRATE 
Product Characteristics
ColorRED (opaque) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:42507-196-261 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1118 mL in 1 BOTTLEThis package is contained within the CARTON (42507-196-26)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/13/2008

Labeler - HyVee Inc (006925671)

Revised: 01/2010 HyVee Inc