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cough and sore throat

CVS Pharmacy

CVS Pharmacy, Inc. Cough & Sore Throat Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Dextromethorphan HBr 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

cough and sore throat 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 lbs under 4 years do not use
36-47 lbs 4 - 5 years 1 tsp or 5 mL
48-95 lbs 6 - 11 years 2 tsp or 10 mL

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

cough and sore throat 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 the active ingredients in Children’s Tylenol® Plus Cough & Sore Throat

Children’s

Pain Relief Plus

COUGH & SORE THROAT

SUSPENSION LIQUID

FEVER REDUCER, PAIN RELIEVER

COUGH SUPPRESSANT

CONTAINS 2 INGREDIENTS:

Fever & sore throat – Acetaminophen

Cough – Dextromethorphan HBr

Cherry Flavor

ORAL SUSPENSION

Dosage cup provided

cough and sore throat
Cough & Sore Throat Carton Image 1 Cough & Sore Throat Carton Image 2

cough and sore throat

Acetaminophen, Dextromethorphan HBr SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-196
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
CALCIUM SULFATE
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
SODIUM PHOSPHATE, TRIBASIC

Product Characteristics

Color
RED (opaque)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:59779-196-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-07-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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