DOLOGEN 325- acetaminophen, dexbrompheniramine tablet

Dologen 325 by

Drug Labeling and Warnings

Dologen 325 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 325 mg

Dexbrompheniramine Maleate 1 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. Temporarily relieves runny nose, and sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other respiratory allergies.

Warnings:

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if: you take more than 10 tablets (3,250 mg) in 24 hours in adults or 5 tablets (1,625 mg) in 24 hours for children Adults take more than 4,000 mg of acetaminophen in 24 hours  your child takes more than 5 doses in 24 hours, which is the maximum daily amount  you take with other drugs containing acetaminophen you take 3 or more alcoholic drinks while using this product.

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.

Do not use : with 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.

Do not give this product to children who have breathing problems such as chronic bronchitis, or who have glaucoma, without first consulting a doctor.

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 especially in children 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 in adults pain gets worse or lasts for more than 5 days in children under 12 years  fever gets worse or lasts for more than 3 days new symptoms occur  redness or swelling is present. These could be signs of serious conditions.

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

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). 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 2 tablets every 4 to 6 hours as needed, do not exceed 10 tablets in 24 hours, or as directed by a doctor. Do not use for more than 10 days unless directed by a doctor.
• Children 6 to under 12 years of age: Take 1 tablet every 4 to 6 hours, not to exceed 5 tablets in 24 hours, or as directed by a doctor.
• Children under 6 years of age: 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, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid

SPL UNCLASSIFIED SECTION

NEW IMPROVED FORMULA

• Pain Reliever
• Fever Reducer
• Antihistamine

Sugar & Dye Free

Manufactured in the USA for

Kramer-Novis, San Juan, Puerto Rico 00917  Tel: 787-767-2072

www.kramernovis.com

Packaging

INGREDIENTS AND APPEARANCE

DOLOGEN 325 
acetaminophen, dexbrompheniramine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-482
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	1 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (ivory white)	Score	no score
Shape	CAPSULE (D)	Size	14mm
Flavor		Imprint Code	D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-482-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2014
2	NDC: 52083-482-02	2 in 1 PACKET; Type 0: Not a Combination Product	08/27/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/27/2014

Labeler - Kramer Novis (090158395)

Registrant - Kramer Novis (090158395)