DailyMed - DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable

NDC Code(s): 51660-726-30, 51660-726-61
Packager: Ohm Laboratories Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 15, 2024

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient (in each chewable tablet)
Loratadine USP, 5 mg

Loratadine USP, 5 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 - sneezing - itchy, watery eyes - itching of the nose or throat
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- 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

chew or crush tablets completely before swallowing. adults and children 6 years and over - chew 2 tablets daily; not more than 2 chewable tablets in 24 hours - children 2 to under 6 ...

Other information
phenylketonurics: contains phenylalanine 1.25 mg per tablet. 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 ...
- phenylketonurics: contains phenylalanine 1.25 mg per tablet.
- 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).
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Inactive ingredients
aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
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Questions?
call toll-free Monday to Friday 8:30 am to 5:00 pm EST at - 1-800-406-7984. Keep the carton. It contains important information. See end panel for expiration date.

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Keep the carton. It contains important information. See end panel for expiration date.
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SPL UNCLASSIFIED SECTION
Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 - 0420

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

0420
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PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton
NDC 51660-726-30 - †Compare to the active ingredient of Children's Claritin - ®Chewable - Ages 2+ years - Children's - Loratadine Chewable Tablets USP, 5 mg - Antihistamine - Indoor ...
NDC 51660-726-30

†Compare to the active ingredient of Children's Claritin ®Chewable

Ages 2+ years

Children's

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor & Outdoor Allergies

30 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

Dye-Free

Grape Flavored

Non-Drowsy*

24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
*When taken as directed. See Drug Facts Panel.

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	manufacture(51660-726)

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	RxCUI	RxNorm NAME	RxTTY
1	665078	loratadine 5 MG 24HR Chewable Tablet	PSN
2	665078	loratadine 5 MG Chewable Tablet	SCD

Label: DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable

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adults and children 6 years and over	chew 2 tablets daily; not more than 2 chewable tablets in 24 hours
children 2 to under 6 years of age	chew 1 tablet daily; not more than 1 chewable tablet in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

	NDC
1	51660-726-30
2	51660-726-61

Label: DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable

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Drug Label Info

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Drug Label Information

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Safety

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More Info on this Drug

DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable

Number of versions: 1

DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable

DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable

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DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable

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