FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
- DIPHENHYDRAMINE HCL 12.5 MG/ 5 ML CUPS
- DIPHENHYDRAMINE HCL 12.5 MG/5 ML MAJOR PHARMACEUTICALS - IFU - INSTITUTIONAL USE ONLY
- DIPHENHYDRAMINE HCL 12.5 MG/5 ML MAJOR PHARMACEUTICALS - IFU - FOR INSTITUTIONAL USE ONLY
- DIPHENYDRAMINE HCL 12.5 MG/ 5 ML MAJOR PHARMACEUTICAL - IFU - FOR INSTITUTIONAL USE ONLY
- DIPHENHYDRAMINE HCL 12.5 MG/ 5 ML MAJOR PHARMACEUTICALS - IFU - FOR INTITUTIONAL USE ONLY
- DIPHENHYDRAMINE HCL 12.5 MG/ 5 ML MAJOR PHARMACEUTICALS - IFU - FOR INSTITUTIONAL USE ONLY
- DIPHENHYDRAMINE HCL 25 MG / 10 ML CUPS
- DIPHENHYDRAMINE HCL 25 MG/ 10 ML MAJOR PHARMACEUTICALS - FOR INSTUTIONAL USE ONLY
- DIPHENHYDRAMINE HCL 10 MG/ 10 ML MAJOR PHARMACEUTICALS - FOR INSTITUTIONAL USE ONLY
- DIPHENHYDRAMINE HCL 25 MG/ 10 ML MAJOR PHARMACEUTICALS - FOR INSTITUTIONAL USE ONLY
- DIPHENHYDRAMINE HCL 10 MG / 10 ML MAJOR PHARMACEUTICALS - FOR INSTITUTIONAL USE ONLY
- DIPHENHYDRAMINE HCL 25 MG/ 10 ML MAJOR PHARMACEUTICALS - IFU - FOR INSTITUTIONAL USE ONLY
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Plastikon Healthcare, Llc. 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.
Diphenhydramine Hcl 12.5 Mg/ 5 Ml Cups
NDC 0904-6740-70
Diphenhydramine HCl
Oral Solution, USP
12.5 mg/5 mL
Antihistamine - Delivers 5 mL
See Insert
For Instituional Use Only
MAJOR PHARMACEUTICALS
Livonia, MI 64152
Sugar Free - Dye Free - Alcohol Free
Diphenhydramine Hcl 12.5 Mg/5 Ml Major Pharmaceuticals - Ifu - Institutional Use Only
Directions
• Use the following dosage guidelines when using this product
Age (yr)
Dose (mL)
adults and children 12 years and over
take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours
children 6 years to under 12 years
take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours
children under 6 years
ask a doctor
Diphenhydramine Hcl 12.5 Mg/5 Ml Major Pharmaceuticals - Ifu - For Institutional Use Only
Warnings
Do not use
in neonates or premature infants
if pregnant or breast-feeding
if hypersensitive to diphenhydramine HCl and other similar antihistamines
with any other product containing diphenhydramine, even one used on skin
to make a child sleepy
___________________________________________________________________
Ask a doctor before use if you have
glaucoma a breathing problem such as emphysema or chronic bronchitis
a sodium restricted diet trouble urinating due to an enlarged prostate gland
___________________________________________________________________
Ask a doctor or pharmacist before use if
taking tranquilizers or sedatives
___________________________________________________________________
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
___________________________________________________________________
Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat
Other information
- each 5 mL contains: sodium 15 mg
- store at 20-25°C (68-77°F)
- protect from excessive moisture
- do not use if lid seal is open or damaged
- sugar free, dye free, alcohol free
- see bottom of cup for lot number and expiration date
Diphenydramine Hcl 12.5 Mg/ 5 Ml Major Pharmaceutical - Ifu - For Institutional Use Only
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)
Diphenhydramine Hcl 12.5 Mg/ 5 Ml Major Pharmaceuticals - Ifu - For Intitutional Use Only
Antihistamine
Diphenhydramine Hcl 12.5 Mg/ 5 Ml Major Pharmaceuticals - Ifu - For Institutional Use Only
Active ingredient (in each 5 mL cup) Purpose Diphenhydramine HCl USP 12.5 mg..………………………………………Antihistamine
Product Insert
Diphenhydramine HCl Oral Solution, USP
NDC 0904-6740-70
10 x 5 mL Unit Dose Cups
Active ingredient (in each 5 mL cup) Purpose Diphenhydramine HCl USP 12.5 mg..………………………………………Antihistamine
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itchy throat
- in neonates or premature infants
- if pregnant or breast-feeding
- if hypersensitive to diphenhydramine HCl and other similar antihistamines
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- a sodium restricted diet
- trouble urinating due to an enlarged prostate gland
- taking tranquilizers or sedatives
- 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
- each 5 mL contains: sodium 15 mg
- store at 20-25°C (68-77°F)
- protect from excessive moisture
- do not use if lid seal is open or damaged
- sugar free, dye free, alcohol free
- see bottom of cup for lot number and expiration date
Warnings
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if
When using this product
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)
Other information
Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose
Directions
Use the following dosage guidelines when using this product
Age (yr) Dose (mL)
adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours
children 6 years to under 12 years take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours
children under 6 years ask a doctor
Questions or comments?
Call 1-800-616-2471
Re-order No. 700900
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
Diphenhydramine Hcl 25 Mg / 10 Ml Cups
NDC 0904-6741-72
Diphenhydramine HCl
Oral Solution, USP
25 mg/10 mL
Antihistamine - Delivers 10 mL
See Insert
For Instituional Use Only
MAJOR PHARMACEUTICALS
Livonia, MI 64152
Sugar Free - Dye Free - Alcohol Free
Diphenhydramine Hcl 25 Mg/ 10 Ml Major Pharmaceuticals - For Instutional Use Only
Directions
Use the following dosage guidelines when using this product
Age (yr) Dose (mL)
adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours
children 6 years to under 12 years ask a doctor
Diphenhydramine Hcl 10 Mg/ 10 Ml Major Pharmaceuticals - For Institutional Use Only
Warnings
Do not use
• in neonates or premature infants
• if pregnant or breast-feeding
• if hypersensitive to diphenhydramine HCl and other similar antihistamines
• with any other product containing diphenhydramine, even one used on skin
• to make a child sleepy
___________________________________________________________________
Ask a doctor before use if you have
• glaucoma • a breathing problem such as emphysema or chronic bronchitis
• a sodium restricted diet • trouble urinating due to an enlarged prostate gland
___________________________________________________________________
Ask a doctor or pharmacist before use if
• taking tranquilizers or sedatives
___________________________________________________________________
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
Diphenhydramine Hcl 25 Mg/ 10 Ml Major Pharmaceuticals - For Institutional Use Only
Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose
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)
Antihistamine
Active ingredient (in each 10 mL cup) Purpose Diphenhydramine HCl USP 25 mg..………………………………………Antihistamine
Diphenhydramine Hcl 10 Mg / 10 Ml Major Pharmaceuticals - For Institutional Use Only
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat
Diphenhydramine Hcl 25 Mg/ 10 Ml Major Pharmaceuticals - Ifu - For Institutional Use Only
• each 10 mL contains: sodium 30 mg
- store at 20-25°C (68-77°F)
- protect from excessive moisture
- do not use if lid seal is open or damaged
- sugar free, dye free, alcohol free
- see bottom of cup for lot number and expiration date
- runny nose
- sneezing
- itchy, watery eyes
- itchy throat
- in neonates or premature infants
- if pregnant or breast-feeding
- if hypersensitive to diphenhydramine HCl and other similar antihistamines
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- a sodium restricted diet
- trouble urinating due to an enlarged prostate gland
- taking tranquilizers or sedatives
- 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
- each 10 mL contains: sodium 30 mg
- store at 20-25°C (68-77°F)
- protect from excessive moisture
- do not use if lid seal is open or damaged
- sugar free, dye free, alcohol free
- see bottom of cup for lot number and expiration date
roduct Insert
Diphenhydramine HCl Oral Solution, USP
NDC 0904-6741-72
10 x 10 mL Unit Dose Cups
Active ingredient (in each 10 mL cup) Purpose Diphenhydramine HCl USP 25 mg..………………………………………Antihistamine
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Warnings
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if
When using this product
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
Use the following dosage guidelines when using this product
Age (yr) Dose (mL)
adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours
children 6 years to under 12 years ask a doctor
Other information
Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose
Questions or comments?
Call 1-800-616-2471
Re-order
No. 700901
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
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