FDA Label for Pharbedryl
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(IN EACH BANDED CAPSULE)
- PURPOSE
- USES:
- DO NOT USE
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- ASK A DOCTOR OR PHARMACIST BEFORE USE OF YOU ARE
- WHEN USING THIS PRODUCT
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS:
- OTHER INFORMATION:
- QUESTIONS? ADVERSE DRUG EVENT CALL: (866)562-2756
Pharbedryl Product Label
The following document was submitted to the FDA by the labeler of this product Pharbest Pharmaceuticals, Inc.. 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 Ingredient(In Each Banded Capsule)
Diphenhydramine HCL 25 mg
Purpose
Antihistamine
Uses:
- Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies: -Sneezing
-Nasal congestion
-Runny nose
-Itchy, watery eyes
Do Not Use
- With any other product containing diphenhydramine, even one used on skin.
Ask A Doctor Or Pharmacist Before Use
If you have
- Trouble urinating due to an enlarged prostate gland
- A breathing problem such as emphysema or chronic bronchitis
- Glaucoma
Ask A Doctor Or Pharmacist Before Use Of You Are
Taking sedatives or tranquilizers
When Using This Product
- Avoid alcoholic drinks
- Marked drowsiness may occur
- Excitability may occur, especially in children
- Alcohol, sedatives and tranquilizers may increase drowsiness
- Be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast-Feeding,
Ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
Directions:
- Take every 4-6 hours
- Do not exceed 6 doses in 24 hours.
Adults and children 12 years of age or over | 25 mg to 50 mg (1 to 2 capsules) |
Children 6 to under 12 years of age | 12.5 mg** to 25 mg (1 capsule) |
Children under 6 years | ask a doctor |
Do not attempt to break capsule.
Other Information:
- Tamper Evident: Do not use if safety seal under cap is broken or missing
- Store at controlled room temperature 15°-30°C (59°-86°F)
- Protect from moisture
- Use by expiration date on package
Questions? Adverse Drug Event Call: (866)562-2756
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