Label: DOLOGESIC DF- acetaminophen, dexbrompheniramine maleate tablet
- NDC Code(s): 54859-010-01
- Packager: Llorens Pharmaceutical International Division
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 23, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take
- more than 8 capsules in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminphen
- 3 or more alcoholic drinks every day while using this product
Alcohol Warning: If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.
Do not use
- with any other drug containing acetaminphen (prescription or non-prescription). If you are not sure whether a drug contains acetaminphen ask a doctor or pharmacist
- if you are allergic to acetaminophen or any of the inactive ingredients in the product
- for more than 10 days for pain, unless directed by a doctor
- for more than 3 days for fever, unless directed by a doctor
- May cause drowsiness: alcohol, sedative and tranquilizers may increase the drowsiness effect Avoid alcoholic beverages while taking this product
- Do not take this product if you are taking sedative or tranquilizers without consulting your doctore
- Use cauting when driving motor vehicle or operating machinery.
Ask a doctor or pharmacist before use:
- if you are taking the blood thinning drug warafin
- if you have liver disease
Stop using this product and ask a doctor if:
- pain gets worse or last more than 10 days
- fever gets worse or last more than 3 days
- new symptoms occur
- redness or swelling is present
- these could be signs of a serious condition
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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Directions
Overdose Warning: Taking more than recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or 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
Do not exceed recommended dosage
Age Dose adults and children 12 years of age and over Take 2 caplets every 4-6 hours. Do not take more than 8 caplets in 24 hours, or as directed by a doctor children under 12 years of age Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminphen and could cause liver damage - Inactive ingredients
- Questions or comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOLOGESIC DF
acetaminophen, dexbrompheniramine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-010 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 1 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Product Characteristics Color white Score no score Shape capsule Size 20mm Flavor Imprint Code LLORENS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-010-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/2016 Labeler - Llorens Pharmaceutical International Division (037342305)
