OTC Medication Information: Childrens Pain and Fever Grape

CHILDRENS PAIN AND FEVER GRAPE- acetaminophen liquid
Method Pharmaceuticals, LLC

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.

Children’s Pain & Fever

Acetaminophen Liquid 160 mg/5 mL

Pain Reliever / Fever Reducer

Oral Solution

Alcohol Free/ Aspirin Free/ Ibuprofen Free

Ages 2-11 Years

Grape Flavor

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Purpose

Acetaminophen, USP 160 mg ………………….. 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 you take:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 other drugs 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 pharmac ist before use

if your child is taking the blood thinning drug warfarin

When using this product

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or last for 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.

Overdose warning: 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 overdose warning)
  • mL = milliliter
  • find the right dose on chart below. If possible, use weight to dose: otherwise, use age.
  • remove the child protective cap and dispense your child’s dose into the dosing cup
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL*)
Under 24 Under 2 years ask a doctor
24-35 2-3 years 5 mL
36-47 4-5 years 7.5 mL
48-59 6-8 years 10 mL
60-71 9-10 years 12.5 mL
72-95 11 years 15 mL

*or as directed by a doctor

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

Other Information

  • each 5 mL contains: sodium 3 mg
  • store at 20°C to 25°C (68°F to 77°F)
  • do not use if seal is broken or missing

Inactive Ingredients

Flavor, Glycerin, Masking Agent, Polyethylene Glycol, Citric Acid, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol

Questions or comments ?

1-877-250-3427

Manufactured for:

Method Pharmaceuticals , LLC

Fort Worth, Texas 76118

Rev. 04/2020

PRINCIPAL DISPLAY PANEL

NDC 58657-522-04
Method
Children’s
Pain & Fever
Grape Flavor4 fl. oz. (118 mL)

PRINCIPAL DISPLAY PANEL
NDC 58657-522-04
Method
Children’s
Pain & Fever
Grape Flavor
4 fl. oz. (118 mL)
(click image for full-size original)
CHILDRENS PAIN AND FEVER GRAPE acetaminophen liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58657-522
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
CITRIC ACID MONOHYDRATE
WATER
SODIUM BENZOATE
SODIUM CITRATE
SACCHARIN SODIUM
SORBITOL
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58657-522-04 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 07/01/2020
Labeler — Method Pharmaceuticals, LLC (060216698)

Revised: 07/2020 Method Pharmaceuticals, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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