Label: ALLERGY RELIEF MEDICATION- loratadine tablet
view more11673-315-40, 11673-315-60
- Packager: Target Brands, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose • itchy, watery eyes • sneezing • itching of the nose or throatClose
- Adverse Reactions
- Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.Close
- Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.Close
- When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.Close
- Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.Close
- Pregnancy or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.Close
- Keep Out of Reach of Children
Keep out of reach of children.Close
In case of overdose, get medical help or contact a Poison Control Center right away.Close
- Other Information
- safety sealed: do not use if the imprinted bottle seal with “sealed for your protection” is open or torn (for bottle carton only)
- safety sealed: do not use if the imprinted blister unit is open or torn (for blister carton only)
- store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)
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
- Inactive ingredients
lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolateClose
Distributed by Target Corp.
Minneapolis, MN 55403
copyright 2009 Target Brands, Inc.
All Rights PerseveredClose
- Principal Display
- INGREDIENTS AND APPEARANCE
ALLERGY RELIEF MEDICATION
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11673-315 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 CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code GG;296 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-315-10 2 in 1 CARTON 1 5 in 1 BLISTER PACK 2 NDC:11673-315-40 4 in 1 CARTON 2 10 in 1 BLISTER PACK 3 NDC:11673-315-18 1 in 1 CARTON 3 180 in 1 BOTTLE 4 NDC:11673-315-60 6 in 1 CARTON 4 10 in 1 BLISTER PACK 5 NDC:11673-315-30 3 in 1 CARTON 5 10 in 1 BLISTER PACK 6 NDC:11673-315-15 3 in 1 CARTON 6 5 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075209 01/31/2010 Labeler - Target Brands, Inc. (006961700)