M-Hist PD Liquid

M-Hist PD Liquid

Drug Labeling and Warnings

Drug Details

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M-HIST PD- triprolidine hydrochloride liquid 
Method Pharmaceuticals, 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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M-Hist PD Liquid

58657-535-30
M-Hist PD
Liquid

Drug Facts

Active ingredient (in each mL)

Triprolidine HCl 0.625 mg

Purpose

Antihistamine

Uses

  • temporarily relieves: ■runny nose
  • sneezing ■itching of nose and throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis

Warnings

  • May cause excitability, especially in children

Do Not Use

  • if you or your children are taking sedatives or tranquilizers, without first consulting your doctor
  • with any other product containing triprolidine

Ask a doctor before use if your child has

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

When using this product

  • do not use more than directed
  • may cause drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by a fever

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.

Directions

  • take every 6 hours
  • do not take more than 4 doses in 24 hours or as directed by a doctor
  • do not give more than directed or exceed the recommended daily dosage
  • use only with enclosed dropper
  • do not use enclosed dropper for any other drug product

Adults and children 12 years of age and over       4 mL (2.5 mg)
Children 6 to under 12 years of age             2 mL (1.25 mg)
Children under 6 years of age                   ask a doctor

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Banana flavor, citric acid anhydrous, FD&C Red #40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, strawberry flavor, sucralose.

Questions?

Call 1-877-250-3427

Distributed by:
Method Pharmaceuticals, LLC
Fort Worth, TX 76118

Professional Labeling

Take under guidance of Health Professionals.

Children 4 months to under 2 years of age      0.5 mL (0.313 mg)
Children 2 to under 4 years of age      1 mL (0.626 mg)
Children 4 to under 6 years of age      1.5 mL (0.938 mg)

Take every 6 hours.

Do not exceed 4 doses in 24 hours.

PRINCIPAL DISPLAY PANEL

58657-535-30
M- Hist PD
Liquid
1 mL
1 oz. (30 mL)

PRINCIPAL DISPLAY PANEL
58657-535-30
M- Hist PD
Liquid
1 mL
1 oz. (30 mL)

M-HIST PD 
triprolidine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58657-535
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE0.625 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBANANA, STRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58657-535-301 in 1 CARTON11/08/2016
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/08/2016
Labeler - Method Pharmaceuticals, LLC (060216698)

Revised: 11/2016
 
Method Pharmaceuticals, LLC


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