FDA Label for Biogesic
View Indications, Usage & Precautions
Biogesic Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Generic Corporation. 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.
Otc - Active Ingredient
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain Reliever/Fever Reducer
Dexbrompheniramine maleate 1 mg Antihistamine
Otc - Purpose
Purpose
Antihistamine
Nasal Decongestant
Warnings
Warnings:
Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your
doctor whether you should take acetaminophen or other pain relievers/fever reducers.
Liver Warning: This product contains Acetaminophen. Severe liver damage may
occur if you take
- more than 8 caplets in 24 hours,which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, 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.
- if you have liver disease
- if you are taking the blood thinning drug warfarin.
- pain gets worse or last more than 10 days
- fever gets worse or last more than 3 days
- new symptoms occur n redness or swelling is present
- These could be signs of a serious condition.
- May cause drowsiness: alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product.
- Do not take this product if you are taking sedatives or tranquilizers, without consulting your doctor.
- Use caution when driving motor vehicle or operating machinery.
Do not use
Ask a doctor before use:
Stop using this product and ask a doctor if:
Warnings:
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a Health Professional before use.
Dosage & Administration
Directions: Do not exceed recommended dosage
| 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 acetaminophen and could cause liver damage. |
Indications & Usage
Uses
- For the temporary relief of minor aches and pains associated with
- headache
- muscular aches
- backaches
- minor arthiritis pain
- common cold
- toothaches
- mentrual cramps
- temporarily reduces fever
- itchy and watery eyes due to hay fever
Inactive Ingredient
Inactive ingredients: dicalcium phasphate, microcrystalline cellulose, povidone, silicon dioxide, sodium carboxymethyl starch, starch, stearic acid, talc.
Otc - Questions
Questions or comments?
1-305-403-3788
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