DailyMed - LORATADINE ALLERGY RELIEF- loratadine tablet

NDC Code(s): 76420-330-01, 76420-330-03, 76420-330-05, 76420-330-10, view more
76420-330-11, 76420-330-20, 76420-330-30, 76420-330-31, 76420-330-60, 76420-330-90
Packager: Asclemed USA, Inc.
This is a repackaged label.
Source NDC Code(s): 51660-526

Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 21, 2025

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient (in each tablet)
Loratadine, USP 10 mg

Loratadine, USP 10 mg
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Purpose
Antihistamine

Antihistamine
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Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose - itchy, watery eyes - sneezing - itching of the nose or throat
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
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Warnings
Do not useif you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine ...

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor ifan 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 (1-800-222-1222).

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Directions
adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours - children under 6 years of ageask a doctor - consumers with liver or kidney diseaseask a ...

adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours

children under 6 years of age ask a doctor

consumers with liver or kidney disease ask a doctor

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Other Information
store between 20° to 25° C (68° to 77° F) protect from excessive moisture - TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- store between 20° to 25° C (68° to 77° F)
- protect from excessive moisture
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
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Inactive ingredients
corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
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Questions?
call - 1-800-406-7984

call 1-800-406-7984
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SPL UNCLASSIFIED SECTION
Relabeled and Repackaged by: Enovachem PHARMACEUTICALS - Torrance, CA 90501

Relabeled and Repackaged by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501
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PRINCIPAL DISPLAY PANEL (What is this?)

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INGREDIENTS AND APPEARANCE

Product Information

LORATADINE ALLERGY RELIEF loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76420-330(NDC:51660-526)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (White to Off White)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX526
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76420-330-10	10 in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2025
2	NDC:76420-330-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2025
3	NDC:76420-330-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2025
4	NDC:76420-330-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2025
5	NDC:76420-330-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2025
6	NDC:76420-330-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2025
7	NDC:76420-330-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2025
8	NDC:76420-330-31	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/19/2025
9	NDC:76420-330-11	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/19/2025
10	NDC:76420-330-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076134	11/01/2017

Labeler - Asclemed USA, Inc. (059888437)

Name	Address	ID/FEI	Business Operations
Establishment
ASCLEMED USA INC. DBA ENOVACHEM		059888437	relabel(76420-330) , repack(76420-330)

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Published Date (What is this?)	Version	Files
May 23, 2025	2 (current)	download
Apr 24, 2025	1	download

	RxCUI	RxNorm NAME	RxTTY
1	311372	loratadine 10 MG 24HR Oral Tablet	PSN
2	311372	loratadine 10 MG Oral Tablet	SCD
3	311372	loratadine 10 MG 24 HR Oral Tablet	SY

Label: LORATADINE ALLERGY RELIEF- loratadine tablet

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adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

	NDC
1	76420-330-01
2	76420-330-03
3	76420-330-05
4	76420-330-10
5	76420-330-11
6	76420-330-20
7	76420-330-30
8	76420-330-31
9	76420-330-60
10	76420-330-90

Label: LORATADINE ALLERGY RELIEF- loratadine tablet

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Safety

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Safety

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LORATADINE ALLERGY RELIEF- loratadine tablet

Number of versions: 2

LORATADINE ALLERGY RELIEF- loratadine tablet

LORATADINE ALLERGY RELIEF- loratadine tablet

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LORATADINE ALLERGY RELIEF- loratadine tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.