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cough and sore throat childrens pain relief

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL
Labeler: HyVee Inc
NDC Code: 42507-196

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. Cough & Sore Throat Drug Facts

Active ingredients (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Dextromethorphan HBr 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Uses
  • temporarily relieves the following cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • cough
  • 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

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
  • 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 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

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
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Liver warning)
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
Weight (lb) Age (yr)Dose (tsp or mL)
under 36 lbsunder 4 yearsdo not use
36-47 lbs4 - 5 years1 tsp or 5 mL
48-95 lbs 6 - 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
  • each teaspoon contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not use if printed neckband is broken or missing

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 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

Cherry FLAVOR

ORAL SUSPENSION

Cough & Sore Throat Carton Image 1

Cough & 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 
ANHYDROUS CITRIC ACID 
CALCIUM SULFATE 
SODIUM PHOSPHATE, TRIBASIC 
Product Characteristics
ColorRED (opaque) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:42507-196-261 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/13/2008
Labeler - HyVee Inc (006925671)

Revised: 07/2012
 
HyVee Inc

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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