Label: DOLOGEN 325- acetaminophen, dexbrompheniramine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52083-482-02, 52083-482-90 - Packager: Kramer Novis
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 14, 2018
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients (in each caplet)
- Purpose
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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.
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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.
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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:
- Inactive Ingredients:
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
DOLOGEN 325
acetaminophen, dexbrompheniramine tabletProduct 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)
