FDA Label for Siladryl Allergy Medicine
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- WHEN USING THIS PRODUCT
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PACKAGING INFORMATION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL – CUP - 25 MG PER 10 ML/10 ML
Siladryl Allergy Medicine Product Label
The following document was submitted to the FDA by the labeler of this product American Health Packaging. 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 10 ml cup)
Diphenhydramine HCl 25 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
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin.
Ask A Doctor Before Use If You Have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- a sodium restricted diet
Ask A Doctor Or Pharmacist Before Use
if you are taking sedatives or tranquilizers
When Using This Product
- 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 right away (1-800-222-1222).
Directions
- find right dose on chart below
- take every 4 to 6 hours
- do not take more than 6 doses in any 24-hour period
adults and children 12 years and over | 1 cup (10 mL) to 2 cups (20 mL) |
children 6 to under 12 years | 1/2 cup (5 mL) to 1 cup (10 mL) |
children under 6 years | DO NOT USE |
Other Information
- Each 10 mL cup contains: Sodium 28 mg.
- Store between 20° to 25°C (68° to 77°F).
- Protect from light.
- DO NOT USE IF SEAL IS BROKEN.
- This drug product is supplied in 10 mL unit dose cups as:
100 cups (10 x 10) NDC 60687-267-56
Inactive Ingredients
citric acid, D&C red no. 33, FD&C red no. 40, black cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol, water.
Packaging Information
American Health Packaging unit dose cups contain drug product from Silarx Pharmaceuticals, Inc. as follows:
(25 mg per 10 mL / 100 UD) NDC 60687-267-56 packaged from NDC 54838-135
Distributed by:
American Health Packaging
Columbus, OH 43217
8426769/0520F
Principal Display Panel
Siladryl Allergy
(Diphenhydramine Hydrochloride)
Liquid Medication
Antihistamine
•Sugar Free • Alcohol Free
FOR INSTITUTIONAL USE ONLY
Store between
20° and 25°C (68° and 77°F).
Protect from light.
8426769/0520F
Principal Display Panel – Cup - 25 Mg Per 10 Ml/10 Ml
NDC 60687- 267-42
Siladryl Allergy
(Diphenhydramine Hydrochloride)
Liquid Medication
Antihistamine
25 mg / 10 mL
Delivers 10 mL
Sugar Free. Alcohol Free.
See package Drug Facts insert for
information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
0426769/0420
* Please review the disclaimer below.