DOLEX CHILDREN PAIN AND FEVER- acetaminophen suspension

Dolex by

Drug Labeling and Warnings

Dolex by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient & Purpose

• 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

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.

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

• 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

Principal Display Panel

INGREDIENTS AND APPEARANCE

DOLEX  CHILDREN PAIN AND FEVER
acetaminophen suspension

Product 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)