Label: PAIN AND FEVER CHILDRENS- acetaminophen suspension
- NDC Code(s): 49580-0282-2, 49580-0282-4, 49580-0282-8
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 16, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)
- 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 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other drug 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
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
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Directions
- this product does not contain directions or complete warnings for adult use
- do not take more than directed (see overdose warning)
- shake well before using
- mL= milliliter
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- find the right dose on chart below. If possible, use weight to dose, use age.
Weight (lb) Age (year) Dose (mL)* under 24 under 2 ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 ml 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL *or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or Comments?
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Principal Display Panel
**Compare to active ingredients in Children's Tylenol® Oral Suspension
children's
pain relief
Acetaminophen 160 mg per 5 mL
oral suspension
Pain Reliever/Fever Reducer
alcohol free
aspirin free
ibuprofen free
for ages 2-11 years
cherry flavor
FL OZ (mL)
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
- Product Label
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INGREDIENTS AND APPEARANCE
PAIN AND FEVER CHILDRENS
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0282 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 CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) BUTYLPARABEN (UNII: 3QPI1U3FV8) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0282-4 1 in 1 BOX 05/31/2016 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:49580-0282-2 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/31/2016 3 NDC:49580-0282-8 1 in 1 BOX 05/31/2016 3 237 mL in 1 BOTTLE, PLASTIC; 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 05/31/2016 Labeler - P & L Development, LLC (101896231)
