Dolex

Acetaminophen · Suspension · Oral

Over the counter

Active ingredient

Active ingredient & Purpose Active ingredient (in each 5 mL) Purpose Acetaminophen 160 mg Pain reliever/ fever reducer

Purpose

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

Uses

Uses For the temporary relief of minor aches and pain due to: a cold headache sore throat toothache and to reduce fever

Warnings

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 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.

Do not use

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

Ask a doctor before use if your child has liver disease.

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

When using this product

When using this product do not exceed recommended dose (see overdose warning).

Stop use and ask a doctor

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. Keep out of reach of children.

Directions

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.

Inactive ingredients

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?

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.

Label text from the FDA structured product label by Pharmadel LLC (revised Mar 4, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Dolex NDC products (1)

NDCStrength & formLabelerType
55758-026Acetaminophen 160 mg/5mL
Suspension
Pharmadel LLCOTC MONOGRAPH DRUG

Frequently asked questions

What is Dolex used for?

Uses For the temporary relief of minor aches and pain due to: a cold headache sore throat toothache and to reduce fever

Who makes Dolex?

Dolex is listed by 1 labeler in the FDA NDC directory, including Pharmadel LLC.