DOLEX FORTE- acetaminophen, aspirin, caffeine tablet

Dolex Forte by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients and Purpose

• Active Ingredients: Purposes
• Acetaminophen 250 mg.................................: Pain reliever
• Aspirin 250 mg (NSAID*)................................: Pain reliever
• Caffeine 65 mg.................................................: Pain reliever aid

* nonsteroidal anti-inflammatory drug

Uses

Temporarily relieves minor aches and pains due to:

• headache
• a cold
• arthritis
• muscular aches
• toothache
• premenstrual and menstrual cramps

Warnings

Reye's syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

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

Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• shock
• asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Caffeine warning: The recommended dose of this product

contains about as much caffeine as a cup of coffee. Limit
the use of caffeine-containing medications, foods, or
beverages while taking this product because too much
caffeine may cause nervousness, irritability, sleeplessness,
and, occasionally, rapid heartbeat.

Do not use

• if you have ever had an allergic reactionto acetaminophen, aspirin, or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

• you have liver disease
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for:
• diabetes
• gout
• arthritis
• taking any other drug, or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• pain gets worse or lasts for more than 10 days
• redness or swelling is present
• new symptoms occur
• ringing in the ears or loss of hearing occurs
  
  These could be signs of a serious condition.

If pregnant or breast-feeding,

If pregnant or breast-feeding, ask a health
professional before use. It is especially important not
to use aspirin during the last 3 months of pregnancy
unless definitely directed to do so by a doctor because
it may cause problems in the unborn child or
complications during delivery.
Keep out of reach of children. In case of overdose,
get medical help or contact a Poison Control Center
right away (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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Liver warning:

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

• more than 8 caplets in 24 hours, which is the

maximum daily amount

• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this

product

Directions

• do not use more than directed
• drink a full glass of water with each dose
• adults and children 12 years and over: take 4 to 8 tablets every 4 hours; do not exceed 48 tablets in 24 hours
• children under 12 years: consult a doctor

Other information

• store between 20°-25°C (68°-77°F) in a dry place
• retain carton for complete product information

Inactive ingredients

carnauba wax, colloidal
silicon dioxide, hypromellose, microcrystalline
cellulose, mineral oil, povidone, pregelatinized starch,
sodium starch glycolate, stearic acid, titanium dioxide

Questions?

1-866-359-3478 (M-F) 9AM to 5PM EST
or www.pharmadel.com

Principal Display Panel

DOLEX®

FORTE

EXTRA STRENGTH

Acetaminophen, Aspirin ,Caffeine

Pain reliever/Pain reliever Aid

24 Caplets

INGREDIENTS AND APPEARANCE

DOLEX FORTE 
acetaminophen, aspirin, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE (UNII: FZ989GH94E)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	CAPSULE ((Capsule-Shaped Tablet))	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-019-24	1 in 1 CARTON	03/25/2013
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 not final	part356	01/25/2013

Labeler - Pharmadel LLC (030129680)