ACTIDOGESIC DF- acetaminophen, dexbrompheniramine maleate tablet

ACTIDOGESIC DF by

Drug Labeling and Warnings

ACTIDOGESIC DF by is a Otc medication manufactured, distributed, or labeled by Actipharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each caplet)

Acetaminophen, 500 mg

Dexbrompheniramine Maleate, 1 mg

Purpose

Pain reliever/Fever reducer

Antihistamine

INDICATIONS & USAGE

Uses For the temporary relief of minor aches and pains associated with headache muscular aches backaches minor arthritis pain common cold toothaches menstrual cramps temporarily reduces fever itchy and watery eyes due to hay fever.

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets (4,000 mg) 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

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

Caution: May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. 

Do not use with any other drug containing acetaminophen (prescription or non-prescription) this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are allergic to acetaminophen or any of the inactive ingredients in the product for more than 10 days for pain, unless directed by a doctor.

Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.

Ask a doctor before use 

if you have liver disease if you are taking the blood thinning drug warfarin.

Stop using this product and ask a doctor if

pain gets worse or lasts more than 10 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.

If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away (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.

Keep out of reach of children.

Directions Do not exceed recommended dosage

• Adults and children 12 years of age and older:

  Take 2 caplets every 4 to 6 hours as needed,

  do not exceed 8 caplets in 24 hours, or as

  directed by a doctor, do not use for more than

  10 days unless directed by a doctor.

• Children under 12 years of age: Do not use.

Other Information

Tamper Evident. Do not use if inner seal is torn, broken, or missing

Store at controlled room temperature 15°- 30°C (59°- 86°F)

Avoid excessive heat or humidity

INACTIVE INGREDIENT

Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

SPL UNCLASSIFIED SECTION

ANALGESIC FEVER REDUCER

ANTIHISTAMINE

Contains the same active ingredients as Dologesic® - DF*

SUGAR FREE

DYE FREE

ActiPharma

COMMITTED TO HEALTH AND WELL-BEING

Manufactured in the USA

for ActiPharma, Inc.

Dorado, PR 00646.

Tel: (787) 608-0882

* Dologesic® - DF is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

Packaging

INGREDIENTS AND APPEARANCE

ACTIDOGESIC DF 
acetaminophen, dexbrompheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63102-403
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	1 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	2 pieces
Shape	capsule	Size	17mm
Flavor		Imprint Code	A403
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63102-403-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/10/2020

Labeler - Actipharma, Inc (079340948)