Label: BETTER LIVING BRANDS CHILDRENS FEVER AND PAIN RELIVER- acetaminophen suspension
- NDC Code(s): 21130-746-04
- Packager: BETTER LIVING BRANDS LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 27, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (per 5 mL)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
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- more than 5 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Stop use and ask a doctor if
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- new symptoms occur
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- pain gets worse or lasts more than 3 days
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- fever gets worse or lasts more than 5 days
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- 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 right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.
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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).
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- Shake well before using
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- Find right dose on chart below. (If possible, use weight to determine dosing; otherwise, use age.)
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- Pour liquid into dosing cup to the appropriate amount for your child’s weight and/or age.
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- Only use with enclosed dosing cup.
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- If needed, repeat dose every 4 hours while symptoms last.
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- Do not give more than 5 times in any 24-hour period (see overdose warning).
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- Do not give more than 5 days unless directed by a doctor.
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- 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
- Inactive ingredients
- Questions or comments?
-
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
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- PARABEN FREE
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- DYE FREE
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- NO ARTIFICIAL COLOR
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- NO ASPIRIN OR LBUPROFEN
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- 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.
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INGREDIENTS AND APPEARANCE
BETTER LIVING BRANDS CHILDRENS FEVER AND PAIN RELIVER
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-746 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-746-04 1 in 1 CARTON 04/02/2019 1 118 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 Drug M013 04/02/2019 Labeler - BETTER LIVING BRANDS LLC (009137209)
