Country: United States
Language: English
Source: NLM (National Library of Medicine)
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
NuCare Pharmaceuticals, Inc.
ORAL
OTC DRUG
Antihistamine 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
Abbreviated New Drug Application
LORATADINE ALLERGY RELIEF- LORATADINE TABLET NUCARE PHARMACEUTICALS, INC. ---------- DRUG FACTS ACTIVE INGREDIENT(S) Loratadine USP, 10 mg PURPOSE Antihistamine USE(S) 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 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 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 and kidney disease ask a doctor OTHER INFORMATION store between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. INACTIVE INGREDIENTS Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch QUESTIONS? Call 1-800-406-7984 PRINCIPAL DISPLAY PANEL LORATADINE ALLERGY RELIEF loratadine tablet PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 8 0 71-320 8 (NDC:516 6 0 -526 ) ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH LO RATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH STARCH, CO RN (UNII: O8 232NY3SJ) NuCare Pharmaceuticals, Inc. LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X) MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 ) PRODUCT CHARACTERISTICS COLOR white (White to O Read the complete document