DailyMed - LORATADINE tablet

NDC Code(s): 71335-2431-1, 71335-2431-2, 71335-2431-3, 71335-2431-4, view more
71335-2431-5, 71335-2431-6, 71335-2431-7, 71335-2431-8, 71335-2431-9
Packager: Bryant Ranch Prepack
This is a repackaged label.
Source NDC Code(s): 70010-162

Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated July 9, 2024

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ACTIVE INGREDIENT(S)
Loratadine 10 mg

Loratadine 10 mg
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PURPOSE
Antihistamine

Antihistamine
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USE(S)
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose -  sneezing -  itchy, water eyes ...

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

 runny nose

 sneezing

 itchy, water eyes

 itching of the nose or throat
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WARNINGS
DO NOT USE - if you have ever had an allergic reaction to this product or any of its ingredients

DO NOT USE

if you have ever had an allergic reaction to this product or any of its ingredients

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ASK A DOCTOR BEFORE USE IF
you have liver or kidney disease. Your doctor should determine if you need a different dose.

you have liver or kidney disease. Your doctor should determine if you need a different dose.
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WHEN USING THIS PRODUCT
do not take more than directed. Taking more than directed may cause drowsiness.

do not take more than directed. Taking more than directed may cause drowsiness.
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STOP USE AND ASK DOCTOR IF
an allergic reaction to this product occurs. Seek medical help right away.

an allergic reaction to this product occurs. Seek medical help right away.
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PREGNANCY/BREASTFEEDING
ask a health professional before use

ask a health professional before use
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KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control Center right away.

In case of overdose, get medical help or contact a Poison Control Center right away.
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DIRECTIONS
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 ...

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
Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken - Blister Foil Units - safety sealed: do not use if the individual ...

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Blister Foil Units

safety sealed: do not use if the individual blister unit is open or torn
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STORAGE
store between 20º to 25ºC (68º to 77ºF)

store between 20º to 25ºC (68º to 77ºF)
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INACTIVE INGREDIENTS
Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized
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QUESTIONS OR COMMENTS
Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.
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HOW SUPPLIED
Loratadine 10 mg. NDC: 71335-2431-1: 20 Tablets in a BOTTLE - NDC: 71335-2431-2: 30 Tablets in a BOTTLE - NDC: 71335-2431-3: 60 Tablets in a BOTTLE - NDC: 71335-2431-4: 14 Tablets in a BOTTLE - NDC ...

Loratadine 10 mg.

NDC: 71335-2431-1: 20 Tablets in a BOTTLE

NDC: 71335-2431-2: 30 Tablets in a BOTTLE

NDC: 71335-2431-3: 60 Tablets in a BOTTLE

NDC: 71335-2431-4: 14 Tablets in a BOTTLE

NDC: 71335-2431-5: 10 Tablets in a BOTTLE

NDC: 71335-2431-6: 90 Tablets in a BOTTLE

NDC: 71335-2431-7: 28 Tablets in a BOTTLE

NDC: 71335-2431-8: 15 Tablets in a BOTTLE

NDC: 71335-2431-9: 100 Tablets in a BOTTLE

Store between 20º to 25ºC (68º to 77ºF).

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
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PRINCIPAL DISPLAY PANEL (What is this?)
Loratadine 10mg Tablet

Loratadine 10mg Tablet

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INGREDIENTS AND APPEARANCE

Product Information

LORATADINE loratadine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:71335-2431(NDC:70010-162)
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)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white (White to off white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	G;10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-2431-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2024
2	NDC:71335-2431-2	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2024
3	NDC:71335-2431-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2024
4	NDC:71335-2431-4	14 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2024
5	NDC:71335-2431-5	10 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2024
6	NDC:71335-2431-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2024
7	NDC:71335-2431-7	28 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2024
8	NDC:71335-2431-8	15 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2024
9	NDC:71335-2431-9	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210722	01/01/2020

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-2431) , RELABEL(71335-2431)

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	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 tablet

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DO NOT USE

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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	71335-2431-1
2	71335-2431-2
3	71335-2431-3
4	71335-2431-4
5	71335-2431-5
6	71335-2431-6
7	71335-2431-7
8	71335-2431-8
9	71335-2431-9

Label: LORATADINE tablet

View Package Photos

Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

DO NOT USE

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Safety

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More Info on this Drug

LORATADINE tablet

Number of versions: 1

LORATADINE tablet

LORATADINE tablet

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LORATADINE tablet

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