Little Remedies Childrens Fever Pain Reliever

Little Remedies Childrens Fever Pain Reliever
SPL v7
SPL
SPL Set ID e1e44c85-d10c-4997-8f85-064cda7906eb
Route
ORAL
Published
Effective Date 2025-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Propylene Glycol Polyethylene Glycol, Unspecified Water Sucralose Xanthan Gum High Fructose Corn Syrup Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2010-09-01 Until 2021-06-30

Description

Drug Facts

Purpose

Pain Reliever/Fever Reducer


Medication Information

Purpose

Pain Reliever/Fever Reducer

Description

Drug Facts

Uses

Temporarily:

  • reduces fever

  • relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.
Section 42229-5

Drug Facts

Overdose

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 right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs of symptoms.

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.
Directions

This product does not contain directions or complete warnings for adult use.

  • Do not give more than directed (see overdose warning).

  • Shake well before using.

  • Find the right dose on the chart below. (If possible, use weight to determine dosing; otherwise, use age.)

  • Invert bottle and gently squeeze liquid into AccuSafeTM dosing cup to the appropriate amount for your child’s weight and/or age.

  • Only use with enclosed AccuSafeTM dosing cup.

  • If needed, repeat dose every 4 hours while symptoms last.

  • Do not give more than 5 days in any 24-hour period (see overdose warning).

  • Do not give more than 5 days unless directed by a doctor.

  • Replace cap tightly to maintain child resistance.
Weight (lb) Age (yr) Dose
Under 24 Under 2 Ask a doctor
24-35 2 – Under 4 1 tsp or 5mL
36-47 4 – Under 6 1 ½ tsp or 7.5mL
48-59 6 – under 9 2 tsp or 10 mL
60-71 9 – under 11 2 ½ tsp or 12.5mL
72-95 11 – under 12 3 tsp or 15mL
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.

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.

Questions?

For further information you may contact us at: 1-800-7-LITTLE Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST, or visit us at www.LittleRemedies.com.

Ask A Doctor

if your child is taking the blood thinning drug warfarin.

Active Ingredient

(in each 5 mL teaspoon)

Acetaminophen 160mg

Other Information
  • Store at 20-25ºC (68-77ºF)

  • AccuSafeTM Dosing cup enclosed.

  • Tamper Evident: DO NOT USE if printed skrink band on bottle is broken or missing. 

  • Check expiration date on bottle or box before using.
Inactive Ingredients:

Citric Acid, Glycerin, High Fructose Corn Syrup, Natural Flavors, Polyethylene Glycol, Propylene Glycol, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum

Ask A Doctor Before Use

if your child has liver disease.

Principal Display Panel

Little Remedies®

CHILDREN’S FEVER + PAIN RELIEVER

Acetaminophen

NATURAL CHERRY FLAVOR

4 FL OZ (118 mL)

When Using This Product,

DO NOT EXCEED RECOMMENDED DOSAGE: taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage.

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.

Structured Label Content

Uses

Temporarily:

  • reduces fever

  • relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.
Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain Reliever/Fever Reducer

Overdose

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 right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs of symptoms.

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.
Directions

This product does not contain directions or complete warnings for adult use.

  • Do not give more than directed (see overdose warning).

  • Shake well before using.

  • Find the right dose on the chart below. (If possible, use weight to determine dosing; otherwise, use age.)

  • Invert bottle and gently squeeze liquid into AccuSafeTM dosing cup to the appropriate amount for your child’s weight and/or age.

  • Only use with enclosed AccuSafeTM dosing cup.

  • If needed, repeat dose every 4 hours while symptoms last.

  • Do not give more than 5 days in any 24-hour period (see overdose warning).

  • Do not give more than 5 days unless directed by a doctor.

  • Replace cap tightly to maintain child resistance.
Weight (lb) Age (yr) Dose
Under 24 Under 2 Ask a doctor
24-35 2 – Under 4 1 tsp or 5mL
36-47 4 – Under 6 1 ½ tsp or 7.5mL
48-59 6 – under 9 2 tsp or 10 mL
60-71 9 – under 11 2 ½ tsp or 12.5mL
72-95 11 – under 12 3 tsp or 15mL
Do Not Use (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.

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.

Questions?

For further information you may contact us at: 1-800-7-LITTLE Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST, or visit us at www.LittleRemedies.com.

Ask A Doctor (Ask a doctor)

if your child is taking the blood thinning drug warfarin.

Active Ingredient

(in each 5 mL teaspoon)

Acetaminophen 160mg

Other Information
  • Store at 20-25ºC (68-77ºF)

  • AccuSafeTM Dosing cup enclosed.

  • Tamper Evident: DO NOT USE if printed skrink band on bottle is broken or missing. 

  • Check expiration date on bottle or box before using.
Inactive Ingredients:

Citric Acid, Glycerin, High Fructose Corn Syrup, Natural Flavors, Polyethylene Glycol, Propylene Glycol, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum

Ask A Doctor Before Use (Ask a doctor before use)

if your child has liver disease.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Little Remedies®

CHILDREN’S FEVER + PAIN RELIEVER

Acetaminophen

NATURAL CHERRY FLAVOR

4 FL OZ (118 mL)

When Using This Product, (When using this product,)

DO NOT EXCEED RECOMMENDED DOSAGE: taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage.

Stop Use and Ask A Doctor If: (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.

Advanced Ingredient Data


Raw Label Data

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