Geri-Dryl Allergy Relief: Package Insert and Label Information

GERI-DRYL ALLERGY RELIEF- diphenhydramine hydrochloride tablet, coated
RedPharm Drug, 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 tablet)

Diphenhydramine Hydrochloride 25mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:
  • runny nose

  • sneezing
  • itching of the nose and throat
  • itchy, watery eyes

Warnings

Do not use

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

Ask a doctor before use if you have

  • a breathing problem such as chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness

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

  • do not exceed recommended dose
  • adults and children 12 years and over, take 1 to 2 tablets every 4-6 hours, as needed; not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: consult a doctor

Other information

  • each tablet contains: calcium 25mg
  • store at room temperature 15⁰C — 30⁰C (59⁰F — 86⁰F)
  • for institutional use only

Inactive ingredients

cellulose, croscarmellose sodium, D&C red #27 lake, dicalcium phosphate, hypromellose, magnesium stearate, PEG, polysorbate 80, silica, titanium dioxide, wax.

package label

New! Ultra Small Tablets
NDC 57896-681-01

GERICARE
GERI-DRYL
(ALLERGY RELIEF)
Diphenhydramine HCl
Antihistamine
Compare to active ingredient in Benadryl Ultratabs
PACKAGE NOT CHILD RESISTANT
100 Tablets
25 mg each

Geri-dryl allergy relief labelGeri-dryl allergy relief label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL

GERI-DRYL ALLERGY RELIEF
diphenhydramine hcl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67296-1758(NDC:57896-681)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color pink Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code T;061
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-1758-9 24 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 09/01/2011
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 relabel (67296-1758), repack (67296-1758)

Revised: 01/2020 RedPharm Drug, Inc.

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