DOLEX ACETAMINOPHEN 500MG EXTRA STRENGTH- acetaminophen capsule, coated

Dolex Acetaminophen 500mg by

Drug Labeling and Warnings

Dolex Acetaminophen 500mg 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 caplet): Purpose
• Acetaminophen 500 mg: Pain reliever/ fever reducer

Uses

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

• the common cold
• headache
• backache
• muscular aches
• toothache
• minor pain of arthritis
• premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4000mg 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.

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 allergic to of the inactive ingredients in this product

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• any new symptoms occur

These could be signs of a serious condition.

If pregnant or breast feeding,

Keep out of reach of children.

Keep out of reach of children.

Overdose warning:

In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see OVERDOSE WARNING)

​

• Age: Dose
• adults and children 12 years of age and over:
  • take 2 caplets, every 6 hours while symptoms last.
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days, unless directed by a doctor
• children under 12 years of age:
  • consult a doctor

Other information

• store at room temperature 77-86°F (25-30°C)

Inactive ingredients

corn starch,hypromellose,magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone k90, stearic acid, titanium dioxide

Distributed by:

PHARMADEL LLC.

New Castle, DE 19720

1-866-359-3478

Prinicipal Display Panel

INGREDIENTS AND APPEARANCE

DOLEX ACETAMINOPHEN 500MG  EXTRA STRENGTH
acetaminophen capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-372
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM CITRATE (UNII: RHO26O1T9V)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K90 (UNII: RDH86HJV5Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Capsule-Shaped Tablet)	Size	18mm
Flavor		Imprint Code	AP500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-372-24	1 in 1 CARTON	04/07/2023
1		24 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	04/07/2023

Labeler - Pharmadel LLC (030129680)