Label: LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER- acetaminophen liquid
- NDC Code(s): 63029-610-01, 63029-610-02
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 1, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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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 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:
- 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.
Stop use and ask a doctor if
- 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.
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) immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms.
- more than 5 doses in 24 hours, which is the maximum daily amount
-
Directions
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this product does not contain directions or complete warnings for adult use
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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 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
- replace cap tightly to maintain child resistance
mL=mililiter
Weight (lbs) Age (yrs) Dose Under 24 Under 2 Ask a doctor 24-35 2-3 5 mL -
this product does not contain directions or complete warnings for adult use
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-610 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SUCROSE (UNII: C151H8M554) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-610-01 1 in 1 BOX 07/01/2011 1 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63029-610-02 2 in 1 CARTON 07/01/2011 2 59 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 07/01/2011 Labeler - Medtech Products Inc. (122715688)
