Better Living Brands Children’s Fever + Pain Reliever

Better Living Brands Children’s Fever + Pain Reliever
SPL v9
SPL
SPL Set ID c13ced61-c491-4fc2-b83f-78c6d9ad8546
Route
ORAL
Published
Effective Date 2025-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Potassium Sorbate Povidone, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-02

Description

Acetaminophen 160 mg

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Acetaminophen 160 mg

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

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 right dose on chart below. (If possible, use weight to determine dosing; otherwise, use age.)
  • Pour liquid into dosing cup to the appropriate amount for your child’s weight and/or age.
  • Only use with enclosed dosing cup.
  • If needed, repeat dose every 4 hours while symptoms last.
  • Do not give more than 5 times 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 (lbs)

Age (yrs)

Dose

under 24

under 2

Ask a doctor

24-35

2- under 4

5 mL

36-47

4- under 6

7.5 mL

48-59

6- under 9

10 mL

60-71

9- under 11

12.5 mL

72-95

11- under 12

15 mL

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 is allergic to acetaminophen or any of the inactive ingredients in this product.
Other Information
  • Store at room temperature
  • Check expiration date on bottle or box before using
  • DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING
Inactive Ingredients

citric acid, glycerin, natural flavor, potassium sorbate, povidone, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-866-467-2748

Principal Display Panel

NDC 21130-746-04

Compare to the active ingredient in Little Remedies ®Children’s Fever + Pain Reliever*

Children’s Fever + Pain Reliever

ACETAMINOPHEN160 mg/ 5mL

PAIN RELIEVER AND FEVER REDUCER

  • PARABEN FREE
  • DYE FREE
  • NO ARTIFICIAL COLOR
  • NO ASPIRIN OR LBUPROFEN
  • NO HIGH FRUCTOSE CORN SYRUP

For Age 2-11

NATURAL GRAPE FLAVOR

4 FL. OZ. (118 mL)

DISTRIBUTED BY:

LUCERNE NORTH AMERICA LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-866-578-4935

Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Prestige Consumer trademark Little Remedies ®Children’s Fever + Pain Reliever.

When Using This Product

do not exceed recommended dose (see overdose warning)

Active Ingredient (per 5 Ml)

Acetaminophen 160 mg

Stop Use and Ask A Doctor If
  • new symptoms occur
  • pain gets worse or lasts more than 3 days
  • fever 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 right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If Your Child Has

liver disease

Ask A Doctor Or Pharmacist Before Use If the Child Is

taking the blood thinning drug warfarin


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.
Purpose

Pain reliever/Fever reducer

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

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 right dose on chart below. (If possible, use weight to determine dosing; otherwise, use age.)
  • Pour liquid into dosing cup to the appropriate amount for your child’s weight and/or age.
  • Only use with enclosed dosing cup.
  • If needed, repeat dose every 4 hours while symptoms last.
  • Do not give more than 5 times 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 (lbs)

Age (yrs)

Dose

under 24

under 2

Ask a doctor

24-35

2- under 4

5 mL

36-47

4- under 6

7.5 mL

48-59

6- under 9

10 mL

60-71

9- under 11

12.5 mL

72-95

11- under 12

15 mL

Do Not Use (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 is allergic to acetaminophen or any of the inactive ingredients in this product.
Other Information (Other information)
  • Store at room temperature
  • Check expiration date on bottle or box before using
  • DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

citric acid, glycerin, natural flavor, potassium sorbate, povidone, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

NDC 21130-746-04

Compare to the active ingredient in Little Remedies ®Children’s Fever + Pain Reliever*

Children’s Fever + Pain Reliever

ACETAMINOPHEN160 mg/ 5mL

PAIN RELIEVER AND FEVER REDUCER

  • PARABEN FREE
  • DYE FREE
  • NO ARTIFICIAL COLOR
  • NO ASPIRIN OR LBUPROFEN
  • NO HIGH FRUCTOSE CORN SYRUP

For Age 2-11

NATURAL GRAPE FLAVOR

4 FL. OZ. (118 mL)

DISTRIBUTED BY:

LUCERNE NORTH AMERICA LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-866-578-4935

Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Prestige Consumer trademark Little Remedies ®Children’s Fever + Pain Reliever.

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

Active Ingredient (per 5 Ml) (Active ingredient (per 5 mL))

Acetaminophen 160 mg

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
  • pain gets worse or lasts more than 3 days
  • fever 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. (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 right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)