FDA.reportPublic FDA data

Little Remedies Childrens Fever Pain Reliever

Manufacturer
Medtech Products Inc.
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:52:44

Label at a glance#

ProductLittle Remedies Childrens Fever Pain Reliever
Active ingredientACETAMINOPHEN
Label structure12 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 the right dose on the chart below. (If possible, use weight to determine dosing; otherwise, use age.) Invert bottle and gently squeeze liquid into AccuSafe TM dosing cup to the appropriate amount for your child’s weight and/or age. Only use with enclosed ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoon)
Acetaminophen 160mg

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.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if your child has liver disease.

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if your child is taking the blood thinning drug warfarin.

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.

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.

When using this product,

OTC - WHEN USING SECTION

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:

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:

OVERDOSAGE SECTION

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.

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 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 24Under 2Ask a doctor
24-352 – Under 41 tsp or 5mL
36-474 – Under 61 ½ tsp or 7.5mL
48-596 – under 92 tsp or 10 mL
60-719 – under 112 ½ tsp or 12.5mL
72-9511 – under 123 tsp or 15mL

Other Information

OTHER SAFETY 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:

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Little Remedies®
CHILDREN’S FEVER + PAIN RELIEVER
Acetaminophen
NATURAL CHERRY FLAVOR
4 FL OZ (118 mL)

Little Remedies® CHILDREN’S FEVER + PAIN RELIEVER Acetaminophen NATURAL CHERRY FLAVOR 4 FL OZ (118 mL)Little Remedies® CHILDREN’S FEVER + PAIN RELIEVER Acetaminophen NATURAL CHERRY FLAVOR 4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Little Remedies®
CHILDREN’S FEVER + PAIN RELIEVER
Acetaminophen
NATURAL GRAPE FLAVOR
4 FL OZ (118 mL)

Little Remedies® CHILDREN’S FEVER + PAIN RELIEVER Acetaminophen NATURAL GRAPE FLAVOR 4 FL OZ (118 mL)Little Remedies® CHILDREN’S FEVER + PAIN RELIEVER Acetaminophen NATURAL GRAPE FLAVOR 4 FL OZ (118 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN7
307668acetaminophen 32 MG/ML Oral SuspensionSCD7
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY7
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY7
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY7
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY7
307668APAP 32 MG/ML Oral SuspensionSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-602-02Little Remedies Childrens Fever Pain Reliever118 mL in 1 BOTTLELIQUID1187
63029-602-02Little Remedies Childrens Fever Pain Reliever1 in 1 CARTONLIQUID17
63029-603-02Little Remedies Childrens Fever Pain Reliever1 in 1 CARTONLIQUID17
63029-603-02Little Remedies Childrens Fever Pain Reliever118 mL in 1 BOTTLELIQUID1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-602LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER (ACETAMINOPHEN) LIQUID [MEDTECH PRODUCTS INC.]7Legacy NDC, 2 package rows20250116_e1e44c85-d10c-4997-8f85-064cda7906eb.zip
63029-603LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER (ACETAMINOPHEN) LIQUID [MEDTECH PRODUCTS INC.]7Current NDC, Legacy NDC, 2 package rows20250116_e1e44c85-d10c-4997-8f85-064cda7906eb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D3
ACETAMINOPHENACTIVE MOIETY362O9ITL9D3
CITRIC ACIDINACTIVE INGREDIENT2968PHW8QP3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1A3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD43
WATERINACTIVE INGREDIENT059QF0KO0R3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE3

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-60263029-602-02
63029-60363029-603-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
SODIUM BENZOATEOJ245FE5EUIACT
ACETAMINOPHEN362O9ITL9DACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 124 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route
38 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
36 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii+route
38 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSOLUTION / ORAL10000 mgExact identifier — unii+route
6 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
36 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION, EXTENDED RELEASE / ORAL3000 mgExact identifier — unii+route
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
36 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route
38 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
36 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii+route
38 equally ranked IID candidates

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 Childrens Fever Pain RelieverACETAMINOPHENMedtech Products Inc.e1e44c85-d10c-4997-8f85-064cda7906eb2025-01-17WarningsExact identifier
ndc (package): 63029-603-02
ndc (package): 63029-602-02
ndc (product): 63029-603
ndc (product): 63029-602
ndc11 (package): 63029060302
ndc11 (package): 63029060202
spl id: 872cde06-d33f-4677-9c23-1ae8e5a401ab
spl set id: e1e44c85-d10c-4997-8f85-064cda7906eb

Reported adverse events (FAERS/openFDA)#

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