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NARAMIN

Dosage form: solution
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: National Pharma Industries Inc
NDC Code: 58292-010

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

NARAMIN Antihistamine Oral Solution

NARAMIN Antihistamine Oral Solution

Active ingredient (per 5 ml = one pre-filled whistle)*

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

For the temporary relief of these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

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
  • difficulty in urination due to enlargement of the prostate gland
  • a sodium-restricted diet
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you

are taking sedatives or tranquilizers

When using this product

marked drowsiness may occur

avoid alcoholic beverages

alcohol, sedatives, and tranquilizers may increase the drowsiness effect

use caution when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Choking Hazard: Small parts. Keep out of reach of 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years of age and over

Take 2-4 pre-filled whistles every 4 to 6 hours, not to exceed 24 whistles in 24 hours, or as directed by a doctor

Children 6 to under 12 years of age

Take 1-2 pre-filled whistles every 4 to 6 hours, not to exceed 12 whistles in 24 hours, or as directed by a doctor

Children under 6 years of age

Consult a doctor

Other information
  • Each pre-fille whistle contains 14 mg of sodium
  • Protect from light.
  • SAFETY SEALED: This product is protected by a sealed pouch. Do not use if individual foil pouch is torn or damaged.
  • Whistle is not child resistant. Do not remove whistle from child resistant foil pouch prior to use.
  • Store between 68 degrees-77 degrees F (20 degrees - 25 degrees C)
  • Store in outer carton until contents are used.

Inactive ingredients

anhydrous citric acid, DandC red no. 33, FDandC red no.40, flavor, glycerin, monoammonium glycyrrhizinate, poloxamer 407, sodium benzoate, sodium chloride, sodium citrate, sucrose, water

Questions or comments?

1-855-251-0106

NARAMIN Antihistamine Oral Solution 10-5ml whistles (58292-010-05)


NARAMIN 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58292-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
AMMONIUM GLYCYRRHIZATE 
POLOXAMER 407 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SUCROSE 
WATER 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58292-010-0510 AMPULE (AMPULE) in 1 PACKAGE
15 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/28/2014
Labeler - National Pharma Industries Inc (078725867)
Establishment
NameAddressID/FEIOperations
Plastikon Healthcare, LLC041717941manufacture(58292-010)

Revised: 05/2014
 
National Pharma Industries Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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