FDA Label for Dologesic NF
View Indications, Usage & Precautions
Dologesic NF Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical International Division. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
(in each caplet)
Acetaminophen 500 mg
Dexbrompheniramine Maleate 1 mg
Purpose
Pain reliever/fever reducer
antihistamine
Uses
- For the temporary relief of minor aches and pains associated with
- headache
- muscular aches
- backaches
- minor arthritis pain
- common cold
- toothaches
- menstrual cramps
- temporarily reduces fever
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
- 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.
- if you are taking the blood thinning drug warafin
- if you have liver disease
- 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
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
Ask a doctor or pharmacist before use:
Stop using this product and ask a doctor if:
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - Pregnancy Or Breast Feeding
If you are pregnant or breast-feeding, ask a health professional before use.
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
FD&C Red #40, FD&C Yellow #6, hydrocypropyl methyl cellulose, magnesium stearate, microcrystaline cellulose, propylene glycol, sodium starch glycolate, titanium dioxide, triacetin, tricalcium phosphate
Questions Or Comments
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