Dolex Children Pain and Fever ACETAMINOPHEN PHARMADEL LLC FDA Approved Uses For the temporary relief of minor aches and pain due to: a cold headache sore throat toothache and to reduce fever
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Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient & Purpose Active ingredient (in each 5 mL) Purpose Acetaminophen 160 mg Pain reliever/ fever reducer
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
Strengths
5 ml 160 mg
Treats Conditions
Uses For The Temporary Relief Of Minor Aches And Pain Due To A Cold Headache Sore Throat Toothache And To Reduce Fever
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D
Packaging

Principal Display Panel PDP DCPF

Package Descriptions
  • Principal Display Panel PDP DCPF

Overview

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

Indications & Usage

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

Dosage & Administration

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.

Warnings & Precautions
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.
Purpose

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

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

When Using

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

Stop Use & 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.

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.


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