DOLOGEN- acetaminophen, dexbrompheniramine maleate 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 tablet)

Acetaminophen 500 mg
Dexbrompheniramine maleate 2mg

Purpose

Pain reliver/fever reducer
Antihistamine

Uses

for the temporary relief of minor aches and pains associated with
  headache the common cold  toothache  muscular aches  backache  premenstrual and menstrual cramps  the minor pain from arthritis and reduces fever.
for the temporary relief of  runny nose  sneezing  itching of the nose or throat  itchy, watery eyes due to hay fever.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take  more than 6 tablets 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  blister  rash. if a skin reaction occurs, stop use and seek medical help right away.

Do not use  with any other drug containing acetaminophen (prescription or nonprescription). 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 this product unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland  if you are taking sedatives or tranquilizers, without first consulting your doctor.

Ask a doctor before use if you have liver disease

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

When using this product  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

Stop use and ask a doctor if  pain gets worse or lasts more than 10 days  fever gets worse or lasts more than 3 days  redness or swelling in present  any new symptoms appear 

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. 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 tablet every 4 to 6 hours as needed, do not exceed 6 tablets in 24 hours, or as directed by a doctor.
• children under 12 years of age: consult a doctor

Other information:

tamper evident feature: do not use if security seal is torn, broken, or missing  store at controlled room temperature: 15°- 30° C (59° - 86° F)  avoid excessive heat or humidity

Inactive ingredients:

magnesium stearate, microcrystalline cellulose, sodium starch glycolate, steric acid

Questions or comments? 

1-787-767-2072
Call weekdays from 8:00 am to 4:00 pm AST.
You may also report serious side effects to this phone number

SPL UNCLASSIFIED SECTION

Sugar & Dye Free 

Manufactured for: Kramer Novis
San Juan, PR 00917

Made in USA with imported ingredients

www.kramernovis.com 

Peel the label from the bottom right corner for Drug Facts (continued).

Packaging

INGREDIENTS AND APPEARANCE

DOLOGEN 
acetaminophen, dexbrompheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-483
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	2 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	capsule	Size	19mm
Flavor		Imprint Code	D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-483-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/15/2025

Labeler - Kramer Novis (090158395)

Registrant - Kramer Novis (090158395)