DOLOGESIC NF- acetaminophen, dexbrompheniramine maleate tablet

Dologesic by

Drug Labeling and Warnings

Dologesic by is a Otc medication manufactured, distributed, or labeled by Llorens Pharmaceutical International Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

(in each caplet)

Acetaminophen 500 mg

Dexbrompheniramine Maleate 1 mg

Purpose

Pain reliever/fever reducer

antihistamine

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

Warnings

Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take

• more than 8 capsules in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminphen
• 3 or more alcoholic drinks every day while using this product

Alcohol Warning: If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.

Do not use

• with any other drug containing acetaminphen (prescription or non-prescription). If you are not sure whether a drug contains acetaminphen 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
• for more than 3 days for fever, unless directed by a doctor
• May cause drowsiness: alcohol, sedative and tranquilizers may increase the drowsiness effect Avoid alcoholic beverages while taking this product
• Do not take this product if you are taking sedative or tranquilizers without consulting your doctore
• Use cauting when driving motor vehicle or operating machinery.

Ask a doctor or pharmacist before use: 

• if you are taking the blood thinning drug warafin
• if you have liver disease

Stop using this product and ask a doctor if:

• pain gets worse or last more than 10 days
• fever gets worse or last 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

PREGNANCY OR BREAST FEEDING

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

Directions

Overdose Warning: Taking more than recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or 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

Do not exceed recommended dosage

• Age: Dose
• adults and children 12 years of age and over: Take 2 caplets every 4-6 hours. Do not take more than 8 caplets in 24 hours, or as directed by a doctor
• children under 12 years of age: Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminphen and could cause liver damage

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, hydrocypropyl methyl cellulose, magnesium stearate, microcrystaline cellulose, propylene glycol, sodium starch glycolate, titanium dioxide, triacetin, tricalcium phosphate

Questions or comments

1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLOGESIC  NF
acetaminophen, dexbrompheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-001
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color	orange	Score	no score
Shape	capsule	Size	20mm
Flavor		Imprint Code	LLORENS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-001-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2016
2	NDC: 54859-001-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/01/2016

Labeler - Llorens Pharmaceutical International Division (037342305)