Dologen®
dad63da3-cd1f-42a8-93d5-44b39aae1268
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325 mg Dexbrompheniramine Maleate 1 mg
Purpose
Analgesic, Antipyretic (Fever Reducer) Antihistamine
Medication Information
Purpose
Analgesic, Antipyretic (Fever Reducer)
Antihistamine
Description
Acetaminophen 325 mg Dexbrompheniramine Maleate 1 mg
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.
Section 42229-5
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
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.
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. |
Drug Facts
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, p ovidone, sodium starch glycolate, and stearic acid
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.
Active Ingredients (in Each Caplet)
Acetaminophen 325 mg
Dexbrompheniramine Maleate 1 mg
Structured Label Content
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.
Section 42229-5 (42229-5)
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
Purpose
Analgesic, Antipyretic (Fever Reducer)
Antihistamine
Packaging
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.
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. |
Drug Facts
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, p ovidone, sodium starch glycolate, and stearic acid
Keep Out of Reach of Children. (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.
Active Ingredients (in Each Caplet) (Active Ingredients (in each caplet))
Acetaminophen 325 mg
Dexbrompheniramine Maleate 1 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:43.352281 · Updated: 2026-03-14T22:55:23.037919