Dolex Children Pain & Fever (apta)

Dolex Children Pain & Fever (apta)
SPL v3
SPL
SPL Set ID f9158463-aeb1-5de0-e053-6294a90a748b
Route
ORAL
Published
Effective Date 2023-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Xanthan Gum Cellulose, Microcrystalline Glycerin Butylparaben Anhydrous Citric Acid Fd&c Red No. 40 High Fructose Corn Syrup Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Carboxymethylcellulose Sodium, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01
Description

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

Medication Information

Description

Active ingredient (in each 5 mL) Purpose Acetaminophen 160 mg Pain 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
Section 55105-1

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

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.

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
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

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
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.

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

Principal Display Panel

When Using This Product

do not exceed recommended dose (see overdose warning).

Active Ingredient & Purpose

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.

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.

Structured Label Content

Uses

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

  • a cold
  • headache
  • sore throat
  • toothache
  • and to reduce fever
Section 55105-1 (55105-1)

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

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.

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
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: (Distributed by:)

PHARMADEL LLC.

New Castle, DE 19720

Other Information (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
Overdose Warning: (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.

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

Principal Display Panel

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning).

Active Ingredient & Purpose (Active ingredient & Purpose)

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:50.795311 · Updated: 2026-03-14T23:02:36.495120