FDA.reportPublic FDA data

Better Living Brands Children’s Fever + Pain Reliever

Manufacturer
BETTER LIVING BRANDS LLC
Effective date
2026-10-21
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-10-24 01:01:27

Label at a glance#

Productbetter living brands childrens fever and pain reliver
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

• 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 e...

Storage and handling

• Store at room temperature • Check expiration date on bottle or box before using • DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

Label contents#

Full prescribing information#

Active ingredient (per 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

Temporarily:

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

Warnings

WARNINGS SECTION

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.

Do not use

OTC - DO NOT USE SECTION

  • 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.

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.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

ACETAMINOPHEN 160 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.

CHILDREN'S FEVER and PAIN RELIEVER ACETAMINOPHEN
CHILDREN'S FEVER and PAIN RELIEVER ACETAMINOPHEN

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codealbtsn.com/ugtfcjb130 E9 childrens pain and fever image.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-74621130-746-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-11-20full-release2026-06-01 01:17:24

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
44066cc6-6d4b-4db3-e063-6294a90ac3d7c13ced61-c491-4fc2-b83f-78c6d9ad85462025-11-20WarningsExact identifier
spl set id: c13ced61-c491-4fc2-b83f-78c6d9ad8546

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.