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

pain relief

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. Children’s Pain Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

  • •reduces fever
  • •relieves minor aches and pains due to:
  • •the common cold
  • •flu
  • •headache
  • •sore throat
  • •toothache

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.
  • •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

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 gets worse or lasts more than 5 days
  • •fever gets worse or lasts more than 3 days
  • •new symptoms occur
  • •redness or swelling is present

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
  • •shake well before using
  • •find right dose on chart. 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 directed (see Liver warning)
  • •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 24

under 2 years

ask a doctor

24-35

2-3 years

1 tsp or 5 mL

36-47

4-5 years

1 1/2 tsp or 7.5 mL

48-59

6-8 years

2 tsp or 10 mL

60-71

9-10 years

2 1/2 tsp or 12.5 mL

72-95

11 years

3 tsp or 15 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

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

1-800-632-6900

Package/Label Principal Display Panel

COMPARE TO active ingredient of CHILDREN’S TYLENOL® ORAL SUSPENSION

See side panel

For Ages 2 to 11

Children’s Pain Relief

Acetaminophen

Oral Suspension

Pain Reliever/Fever Reducer

Dye-Free

Non-Staining

Alcohol Free, Aspirin Free, Ibuprofen Free, Gluten Free

No High Fructose Corn Syrup

Dosage Cup Included

Cherry Flavor

80 mg per ½ teaspoon

(160 mg per 5 ml)

pain relief

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-959
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
CALCIUM SULFATE
CARRAGEENAN
GLYCERIN
cellulose, microcrystalline
CARBOXYMETHYLCELLULOSE SODIUM
propylene glycol
PROPYLPARABEN
water
SODIUM BENZOATE
sorbitol
Sucralose
SODIUM PHOSPHATE, TRIBASIC

Product Characteristics

Color
WHITE (opaque,viscous)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:30142-959-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-09-20


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