Good Sense Allergy: Package Insert and Label Information

GOOD SENSE ALLERGY- diphenhydramine hydrochloride solution
REMEDYREPACK INC.

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.

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness

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
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

Age (yr)

Dose (mL)

children under 2 years

do not use

children 2 to 5 years

do not use unless directed by a doctor

children 6 to 11 years

5 mL to 10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

  • each 5 mL contains: sodium 15 mg
  • store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Questions or comments?

1-800-719-9260

DRUG: good sense allergy

GENERIC: Diphenhydramine HCl

DOSAGE: SOLUTION

ADMINSTRATION: ORAL

NDC: 70518-2605-0

COLOR: red

FLAVOR: CHERRY

PACKAGING: 118 mL in 1 BOTTLE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL

INACTIVE INGREDIENT(S):

  • ANHYDROUS CITRIC ACID
  • SODIUM CHLORIDE
  • SODIUM BENZOATE
  • SODIUM CITRATE, UNSPECIFIED FORM
  • SORBITOL
  • GLYCERIN
  • D&C RED NO. 33
  • FD&C RED NO. 40
  • POLOXAMER 407
  • HIGH FRUCTOSE CORN SYRUP
  • WATER
Remedy_Label
(click image for full-size original)
GOOD SENSE ALLERGY
diphenhydramine hcl solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-2605(NDC:0113-0379)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLOXAMER 407
WATER
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE, UNSPECIFIED FORM
SORBITOL
GLYCERIN
Product Characteristics
Color red (Bluish-Red) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2605-0 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (70518-2605-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 02/28/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 03/2020 REMEDYREPACK INC.

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