DOLOGEN- dexbrompheniramine maleate, acetaminophen tablet 
Kramer Novis

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dologen

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

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

image description

DOLOGEN 
dexbrompheniramine maleate, acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-481
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (WHITE) Score2 pieces
ShapeCAPSULE (D) Size19mm
FlavorImprint Code D
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-481-9090 in 1 BOTTLE; Type 0: Not a Combination Product10/11/2011
2NDC:52083-481-022 in 1 PACKET; Type 0: Not a Combination Product10/11/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/11/2011
Labeler - Kramer Novis (090158395)
Registrant - Kramer Novis (090158395)

Revised: 12/2018
Document Id: ddc31276-446c-42f4-9558-04c7c6bff944
Set id: f8490040-51cd-4825-aea7-09a618437d29
Version: 4
Effective Time: 20181229
 
Kramer Novis