ON THE GO-DOSE- diphenhydramine hydrochloride solution 
Perfect Measure LLC

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.

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On The GO-Dose Diphenhydramine HCL Anti-Histamine Oral Solution

On The GO-Dose Diphenhydramine HCL Anti-Histamine Oral Solution

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

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

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 vial 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 vial 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

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

On The GO-Dose Diphenhydramine HCL Anti-Histamine Oral Solution 12.5mg (58292-011-05)

Outer Label

Inner Label

ON THE GO-DOSE 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58292-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58292-011-0510 in 1 PACKAGE01/31/2017
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/28/2014
Labeler - Perfect Measure LLC (080502613)
Registrant - Perfect Measure LLC (080502613)
Establishment
NameAddressID/FEIBusiness Operations
Horizon Pharmaceuticals, Inc.960418825manufacture(58292-011)

Revised: 1/2017
Document Id: 476632b8-7a0a-742a-e054-00144ff88e88
Set id: 3152f596-327a-4f49-9f26-70e2006956bb
Version: 1
Effective Time: 20170131
 
Perfect Measure LLC