Label: DOLEX CHILDREN PAIN AND FEVER- acetaminophen suspension
- NDC Code(s): 55758-026-04
- Packager: Pharmadel LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 4, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- 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
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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- If your child is allergic to acetaminophen or any other of the inactive ingredients in this product
Stop use and ask a doctor if
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- any new symptoms occur
- redness or swelling is present
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 right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children 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
- shake well before using
- use only enclosed dosing cup. Do not use any other dosing device
- mL = milliliter
- use the dose that corresponds to your child's age
Age (years) Dose (mL)* under 2 consult a doctor 2 to under 4 5 mL 4 to under 5 7.5 mL
6 to under 8 10 mL 9 to under 10 12.5 mL 11 to under 12 15 mL *Dose may be repeated every 4 hours while symptoms persist, up to five times a day or as directed by a doctor.
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
DOLEX CHILDREN PAIN AND FEVER
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-026 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 XANTHAN GUM (UNII: TTV12P4NEE) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) GLYCERIN (UNII: PDC6A3C0OX) BUTYLPARABEN (UNII: 3QPI1U3FV8) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-026-04 1 in 1 BOX 01/01/2023 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 01/01/2023 Labeler - Pharmadel LLC (030129680)
