ACTIDOGESIC- dexbrompheniramine maleate, acetaminophen tablet

ACTIDOGESIC by

Drug Labeling and Warnings

ACTIDOGESIC by is a Otc medication manufactured, distributed, or labeled by ACTIPHARMA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients in each caplet:Dexbrompheniramine Maleate 1 mg, Acetaminophen 1mg

PURPOSE

Antihistamine, Pain reliever/fever reducer

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

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.

ASK DOCTOR

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.

DO NOT USE

Do not use

with any other drug containing acetaminophen (prescription or nonprescription) 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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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: FD&C Red #40, FD&C Yellow #6, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, and titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACTIDOGESIC 
dexbrompheniramine maleate, acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63102-402
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	2 pieces
Shape	capsule	Size	17mm
Flavor		Imprint Code	A402
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63102-402-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/14/2016

Labeler - ACTIPHARMA, INC (079340948)

Registrant - ACTIPHARMA, INC (079340948)