DOLEX CHILDREN PAIN AND FEVER- acetaminophen suspension 
Pharmadel LLC

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Dolex Children Pain & Fever (APTA)

Drug Facts

Active ingredient & Purpose

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:

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.

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

Age (years)Dose (mL)*
under 2consult a doctor
2 to under 45 mL
4 to under 5

7.5 mL

6 to under 8 10 mL
9 to under 1012.5 mL
11 to under 1215 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

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

PDP DCPF

DOLEX  CHILDREN PAIN AND FEVER
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-026
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-026-041 in 1 BOX01/01/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/01/2023
Labeler - Pharmadel LLC (030129680)

Revised: 3/2024
Document Id: 12dcac76-11bc-2c3b-e063-6394a90a35c6
Set id: f9158463-aeb1-5de0-e053-6294a90a748b
Version: 3
Effective Time: 20240304
 
Pharmadel LLC