OTC Medication Information: Allergy Relief

ALLERGY RELIEF- loratadine tablet
Geri-Care Pharmaceutical Corp

Active ingredient (in each tablet)

Loratadine, USP 10 mg

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 if you have ever had an allergic reaction to this

product or any of its ingredients.

Ask a doctor before use if you have liver or kidney disease.

Your doctor should determine if you need a different dose.

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

Stop use and ask a doctor if an allergic reaction to this

product occurs. Seek medical help right away.

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

adults and children
12 years and over
1 tablet daily; not more
than 1 tablet in 24 hours
children under 12
years of age
ask a doctor
consumers with liver
or kidney disease
ask a doctor

Other information

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store between 20° to 25°C (68° to 77°F)
  • protect from light

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions?

call 1-800-540-3765

package label

1
(click image for full-size original)

ALLERGY RELIEF
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-658
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 439
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57896-658-03 30 TABLET in 1 BOTTLE None
2 NDC:57896-658-09 90 TABLET in 1 BOTTLE None
3 NDC:57896-658-36 365 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075209 02/01/2020
Labeler — Geri-Care Pharmaceutical Corp (611196254)
Registrant — Geri-Care Pharmaceutical Corp (611196254)

Revised: 11/2022 Geri-Care Pharmaceutical Corp

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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