FDA Label for Ultra Diphenhydramine Hcl
View Indications, Usage & Precautions
Ultra Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Singular Dreamer, Ltd Dba True Marker. 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 5Ml Tsp)
Diphenhydramine HCl, 12.5 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory
allergies:
- runny nose
- sneezing
- itchy
- watery eyes
- itching of the nose or throat
- runny nose
- sneezing
temporarily relieves these symptoms due to the common cold:
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin.
- to make a child sleepy
- glaucoma,
- trouble urinating due to an enlarged prostate gland,
- a breathing problem such as emphysema or chronic bronchitis.
- marked drowsiness may occur
- avoid alcoholic drinks alcohol
- sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery,
- excitability may occur, especially in children .
- If pregnant or breast-feeding, ask a health professional before use
- Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if youare taking sedatives or tranquilizers.
When using this product
Directions
- Take every 4 to 6 hours, or as directed by a doctor.
- Do not exceed recommended dose.
| Adults and Children 12 years of age and over | 10 to 20mL (2 to 4 tsp) not to exceed 300mg in 24 hours |
Children under 6 to under 12 years of age Children under six years of age: | Take 5 to 10ml (1 to 2 tsp) not to exceed 150mg in 24 hours Consult a doctor |
Other Information
- Store at room temperature 15° to 30°C (59° to 86°F)
- Do not refrigerate. Avois excessive heat or humidity
- Protect from light
Inactive Ingredients
CITRIC ACID, FD&C RED NO. 40, GLYCERIN, METHYLPARABEN, PROPYLENE GLYCOL, PROPYLPARABEN, WATER, SODIUM CITRATE, SORBITOL, SUCRALOSE, Strawberry Flavor
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Product Label
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