Little Remedies Infant Fever/Pain Reliever: Package Insert and Label Information

LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER- acetaminophen liquid
Medtech Products Inc.

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.

Drug Facts

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily:

  • reduces fever
  • relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or 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.

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

  • skin reddening
  • blisters
  • rash.

If 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, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use:

  • with any other products containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If your child is allergic to acetaminophen or any of the inactive ingredients in this product.

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.

When using this product do not exceed recommended dosage (see overdose warning .)

Stop use and ask a doctor if

  • new symptoms occur

  • fever gets worse or lasts more than 3 days

  • pain gets worse or lasts more than 5 days

  • redness or swelling is present. These could be signs of a serious condition.

Keep out of reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • t his product does not contain directions or complete warnings for adult us e

  • do not give more than directed (see overdose warning)

  • s hake well before using
  • find the right dose on the chart below. (If possible, use weight to determine dose; otherwise, use age.)

  • only use the enclosed AccuSafe® syringe

  • remove cap, insert syringe to flow restrictor and invert bottle

  • pull back syringe until filled to prescribed level and slowly dispense the liquid into your child’s mouth (toward the inner cheek)

  • if needed, repeat dose every 4 hours while symptoms last

  • do not give more than 5 times in any 24-hour period

  • replace cap tightly to maintain child resistance

mL =mililiter

Weight (lbs) Age (yrs) Dose
Under 24 Under 2 Ask a doctor
24-35 2-3 5 mL

Other information

  • each 5 mL contains: sodium 6 mg

  • store at 20-25º C (68-77º F)

  • AccuSafe® dosing device enclosed

  • check expiration date on bottle or box before using

Inactive ingredients

benzoic acid, carboxymethlcellulose, glycerin, natural berry flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum

Questions?

1-800- 54-8853 Mon. – Fri. 8:00 a.m.to 8:00 p.m. EST

LittleRemedies.com

PRINCIPAL DISPLAY PANEL


Little Remedies®
INFANT

FEVER+PAIN RELIEVER
Acetaminophen 160 mg / 5 mL

natural berry flavor2 FL OZ (59 mL)

PRINCIPAL DISPLAY PANEL

Little Remedies®
INFANT
FEVER+PAIN RELIEVER
Acetaminophen 160 mg / 5 mL

natural berry flavor
2 FL OZ (59 mL)
(click image for full-size original)

LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER acetaminophen liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-610
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
BENZOIC ACID
CARBOXYMETHYLCELLULOSE
GLYCERIN
MICROCRYSTALLINE CELLULOSE
SUCROSE
SODIUM BENZOATE
WATER
XANTHAN GUM
Product Characteristics
Color WHITE Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-610-01 1 BOTTLE in 1 BOX contains a BOTTLE
1 59 mL in 1 BOTTLE This package is contained within the BOX (63029-610-01)
2 NDC:63029-610-02 2 BOTTLE in 1 CARTON contains a BOTTLE
2 59 mL in 1 BOTTLE This package is contained within the CARTON (63029-610-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 07/01/2011
Labeler — Medtech Products Inc. (122715688)

Revised: 01/2020 Medtech Products Inc.

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