Dolex Children Pain & Fever (Deactivated)

Dolex Childrens Pain and Fever by

Drug Labeling and Warnings

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

Drug Details [pdf]

DOLEX CHILDRENS PAIN AND FEVER- acetaminophen liquid 
Pharmadel LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dolex Children Pain & Fever (Deactivated)

Drug Facts

Active ingredient & Purpose

Active ingredient (in each 5 mL = 1 teaspoonful)Purpose
Acetaminophen 160 mgPain reliever/ fever reducer

Uses

temporarily

  • reduces fever

relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash.

If a skin reaction occurs, stop use and seek medical help right away.

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
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

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. Quick 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; tsp = teaspoonful

  • find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.

  • if needed, repeat dose every 4 hours while symptoms last

  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor.

Weight (lb) Age (yr) Dose (mL or tsp)*
under 24undere 2 yearsask a doctor
24-352-3 years5 mL (1 tsp)
36-4745-5 years

7.5 mL (1 1/2 tsp)

48-596-8 years10 mL (2 tsps)
60-719-10 years12.5 mL (2 1/2 tsps)
72-9511 years15 mL (3 tsps)

*or as directed by a doctor


Other information

  • each 5 mL (1 tsp) contains: sodium 2 mg
  • store between 68-77° F (20-25° C)
  • do not refrigerate
  • keep carton for full directions for use

Inactive ingredients

anhydrous citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions?

1-877-798-5944 (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

4 FL OZ (118 mL)

Ages 2 to 11

PDP Dolex Children Cherry

DOLEX CHILDRENS PAIN AND FEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55758-330
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
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55758-330-041 in 1 BOX01/01/202301/01/2023
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 not finalpart34301/01/202301/01/2023
Labeler - Pharmadel LLC (030129680)

Revised: 9/2023
 

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