Little Remedies Infant Fever and Pain Reliever Natural Berry

Manufacturer
Denison Pharmaceuticals, Inc.
Effective date
2019-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:25:36

Label at a glance#

ProductLittle Remedies Infant Fever and Pain Reliever Natural Berry Natural Berry
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. Shake well before using. Find the right dose on the chart below. (If possible, use weight to determine dose; otherwise, use age.) Only use the enclosed AccuSafe TM syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child. Remove cap, attach syringe to flow restrictor and invert bottle....

Label contents#

Full prescribing information#

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 reactions 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.

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

OVERDOSAGE SECTION

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) immediately. 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.

  • Shake well before using.
  • Find the right dose on the chart below. (If possible, use weight to determine dose; otherwise, use age.)
  • Only use the enclosed AccuSafe TM syringe.
  • Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • Remove cap, attach 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).
  • Replace cap tightly to maintain child resistance.
Weight (lbs)Age (yrs)Dose
Under 24Under 2Ask a doctor
24-352-35.0 mL

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

For further information you may contact us at: 1-800-754-8853 Mon. – Fri. 8:00 a.m.to 8:00 p.m. EST, www.LittleRemedies.com.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-90020295-9002-12, 0295-9002-17

Ingredients#

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

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

Source Document#

Source XML · Source PDF

openFDA label cross-check#

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
86d079da-c24f-f07c-e053-2991aa0ae66086d06a0b-68b5-aa21-e053-2991aa0a71192019-04-18WarningsExact identifier
spl id: 86d079da-c24f-f07c-e053-2991aa0ae660
spl set id: 86d06a0b-68b5-aa21-e053-2991aa0a7119

Reported adverse events (FAERS/openFDA)#

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