DOLOGEN- dexbrompheniramine maleate, acetaminophen tablet

Dologen by

Drug Labeling and Warnings

Dologen by is a Otc medication manufactured, distributed, or labeled by Kramer Novis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each caplet)

Acetaminophen 650 mg

Dexbrompheniramine Maleate 2 mg

Purpose

Analgesic, Antipyretic (Fever Reducer)

Antihistamine

Uses:

temporarily relieves minor aches and pains due to: headache common cold toothache  backache  muscular aches  menstrual cramps    minor pain of arthritis relieves runny nose, and sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies. Temporarily reduces fever.

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 caplets (3,900 mg) in 24 hours 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. If skin reaction occurs, stop use and seek medical help right away.

Do not use : with any other product 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. When using this product do not exceed recommended dose.

Ask a doctor before use if you have: liver disease  breathing problems such as emphysema or chronic bronchitis  glaucoma or difficulty in urination due to enlargement of the prostate gland.

Ask a doctor or pharmacist before use if you are taking: the blood thinning drug warfarin  sedatives or tranquilizers

While using this product: excitability may occur  drowsiness may occur; 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.

Stop use and ask a doctor if: pain gets worse or lasts for 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.

KEEP OUT OF REACH OF CHILDREN

Overdose warning: 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.

Directions:

Adults and children 12 years of age and older:	take 1 caplet every 4 - 6 hours or as directed by a doctor Do not exceed 6 caplets in 24 hours
Children under 12 years : Consult a doctor

Other Information:

Tamper Evident. Do not use if seal is broken.

Store at controlled room temperature 15° to 30°C (59° to 86°F).  Avoid excessive heat and humidity.

Inactive Ingredients:

corn starch, hydroxypropylmethylcellulose, maltodextrin,  microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and stearic acid

SPL UNCLASSIFIED SECTION

Pain Reliever

Fever Reducer

Antihistamine

Sugar & Dye Free 

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072

www.kramernovis.com

Packaging

INGREDIENTS AND APPEARANCE

DOLOGEN 
dexbrompheniramine maleate, acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-481
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (WHITE)	Score	2 pieces
Shape	CAPSULE (D)	Size	19mm
Flavor		Imprint Code	D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-481-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/11/2011
2	NDC: 52083-481-02	2 in 1 PACKET; Type 0: Not a Combination Product	10/11/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/11/2011

Labeler - Kramer Novis (090158395)

Registrant - Kramer Novis (090158395)