childrens pain relief plus description, usages, side effects, indications, overdosage, supplying and lots more!

childrens pain relief plus

Kroger Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Kroger Co. Cough and Sore Throat Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (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

  • 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

  • this product does not contain directions or complete warnings for adult use
  • do not use 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
  • do not give more than 5 times in 24 hours
Weight(lb) Age(yr) Dose (tsp or mL)
under 36 under 4 years do not use
36-47 4 to 5 years 1 tsp or 5 mL
48-95 6 to 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.

Other information

  • each teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)
  • do not use if printed neckband is broken or missing

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?

1-800-632-6900

Principal Display Panel

Compare to active ingredients of Children’s Tylenol® Plus Cough & Sore Throat - see back panel

Alcohol Free

For Ages 4 to 11

See New Warnings Information

Children’s

Pain Relief Plus

Cough & Sore Throat

Fever Reducer/Pain Reliever/Acetaminophen

Cough Suppressant/Dextromethorphan HBr

Oral Suspension

Aspirin Free

Dosage Cup Included

Cherry Flavor

Principal Display Panel
Cough and Sore Throat Carton

childrens pain relief plus

Acetaminophen, Dextromethorphan HBr SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-196
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

Product Characteristics

Color
RED (opaque)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:30142-196-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-08-25


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Be sure to consult your doctor before taking any medication!
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