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Dolex Children Pain & Fever (APTA)


Drug Facts


Active ingredient & Purpose


OTC - PURPOSE SECTION

Active ingredient (in each 5 mL)Purpose
Acetaminophen 160 mgPain reliever/ fever reducer

Uses

For the temporary relief of minor aches and pain due to:

  • a cold
  • headache
  • sore throat
  • toothache
  • and to reduce fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

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.

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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

Ask a doctor before use if your child has

liver disease.


Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.


When using this product

do not exceed recommended dose (see overdose warning).


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

Keep out of reach of children.

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 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.


Directions

*Dose may be repeated every 4 hours while symptoms persist, up to five times a day or as directed by a doctor.

Age (years)Dose (mL)*
under 2consult a doctor
2 to under 45 mL
4 to under 57.5 mL
6 to under 8 10 mL
9 to under 1012.5 mL
11 to under 1215 mL
  • this product does not contain directions or complete warnings for adult use

Other information

  • each 5 mL contains: sodium 3 mg
  • store between 68-77° F (20-25° C)
  • do not refrigerate
  • keep carton for full directions for use

Inactive ingredients

anhydrous citric acid, butylparaben, FD&C red # 40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum


Questions?

+1-866-359-3478 (9 AM - 5 PM EST) or pharmadel.com

** This product is not manufactured or distributed by Mcneil Consumer Healthcare, distributor of Children’s Tylenol® Oral Suspension.


Distributed by:

PHARMADEL LLC.

New Castle, DE 19720