FDA.reportPublic FDA data

LITTLE REMEDIES INFANT FEVER PAIN RELIEVER - Berry - 63029-610

Manufacturer
Medtech Products Inc.
Effective date
2026-05-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:56:22

Label at a glance#

ProductLittle Remedies Infant Fever/Pain Reliever
Active ingredientACETAMINOPHEN
Label structure10 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

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 on side panel. (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 prescrib...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5.0 mL)

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 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 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

OTC - ASK DOCTOR SECTION

the child has liver disease.

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

the child is taking the blood thinning drug warfarin. 

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage (see overdose warning).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

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 (1-800-222-1222) right away. 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 the right dose on the chart on side panel. (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 (see overdose warning)
  • do not give more than 5 days unless directed by a doctor
  • replace cap tightly to maintain child resistance

mL=milliliter

Weight (lbs)Age (yrs)Dose
Under 24Under 2Ask a doctor
24-352-35 mL

Other information

OTHER SAFETY INFORMATION

  • each 5 mL contains: sodium 6 mg
  • store at 20-25ºC (68-77ºF)
  • AccuSafe® Oral dosing device enclosed
  • check expiration date on bottle or box before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-754-8853 Mon. – Fri. 8:30 am to 5 :30 pm EST

LittleRemedies.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Little Remedies®
INFANT

FEVER+PAIN RELIEVER
Acetaminophen 160 mg / 5 mL

natural berry flavor
2 FL OZ (59 mL)

Little Remedies® INFANT FEVER+PAIN RELIEVER Acetaminophen 160 mg / 5 mL natural berry flavor 2 FL OZ (59 mL)Little Remedies® INFANT FEVER+PAIN RELIEVER Acetaminophen 160 mg / 5 mL natural berry flavor 2 FL OZ (59 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN5
307675acetaminophen 32 MG/ML Oral SolutionSCD5
307675acetaminophen 160 MG per 5 ML Oral SolutionSY5
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY5
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY5
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY5
307675APAP 32 MG/ML Oral SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-610-01Little Remedies Infant Fever/Pain Reliever59 mL in 1 BOTTLELIQUID595
63029-610-01Little Remedies Infant Fever/Pain Reliever1 in 1 BOXLIQUID15
63029-610-02Little Remedies Infant Fever/Pain Reliever2 in 1 CARTONLIQUID25
63029-610-02Little Remedies Infant Fever/Pain Reliever59 mL in 1 BOTTLELIQUID595

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-61063029-610-01, 63029-610-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
BENZOIC ACID8SKN0B0MIMIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SUCROSEC151H8M554IACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-10-23monthly-update2026-06-03 17:38:28
32024-10-25full-release2026-06-01 00:32:19

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
Little Remedies Infant Fever/Pain RelieverACETAMINOPHENMedtech Products Inc.af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a52026-05-11WarningsExact identifier
ndc (package): 63029-610-02
ndc (package): 63029-610-01
ndc (product): 63029-610
ndc11 (package): 63029061002
ndc11 (package): 63029061001
spl id: 7d735d4c-4cd0-4ab0-80cb-60c26ff28b19
spl set id: af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a5

Reported adverse events (FAERS/openFDA)#

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