说明与适用边界
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spl product data elements
loratadine D loratadine, Pseudoephedrine sulfate LORATADINE LORATADINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED TITANIUM DIOXIDE to off-white 7U0
活性成分 / Active ingredient
Active ingredients (in each tablet) Loratadine 5 mg Pseudoephedrine sulfate 120 mg
用途 / Purpose
Purpose Antihistamine Nasal decongestant
适应证 / Indications and usage
Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose
警告 / Warnings
Warnings Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • 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. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs 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).
禁用事项 / Do not use
Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
咨询医生 / Ask a doctor
使用中 / When using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
停用事项 / Stop use
Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
儿童安全 / Keep out of reach of children
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).
用法用量原文 / Dosage and administration
Directions • do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor
dosage and administration table
<table styleCode="Noautorules" width="100%"><col width="42%"/><col width="58%"/><tbody><tr><td styleCode="Rrule Botrule " valign="top"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode="Botrule Lrule " valign="top"><paragraph>1 tablet every 12 hours; not more than 2 tablets in 24 hours</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph>children under 12 years of age</paragraph></td><td styleCode="Lrule Toprule Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Rrule Botrule Toprule " valign="top"><paragraph>consumers with liver or kidney disease</paragraph></td><td styleCode="Botrule Lrule Toprule " valign="top"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>
其他安全资料 / Other safety information
Other information • each tablet contains: calcium 25 mg • do not use if blister unit is broken or torn • store between 20° to 25°C (68° to 77°F) • keep in a dry place
辅料 / Inactive ingredients
Inactive ingredients croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide
questions
Questions or comments? 1-800-719-9260
package label principal display panel
Package/Label Principal Display Panel Compare to Claritin-D ® 12 Hour active ingredients Loratadine-D 12 Hour Pseudoephedrine Sulfate 120 mg / Loratadine 5 mg Extended Release Tablets Nasal Decongestant / Antihistamine Relief of: • Nasal and Sinus Congestion Due to Colds or Allergies • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose Due to Allergies Indoor & Outdoor Allergies 12 Hour Allergy & Congestion 20 Tablets Non-Drowsy* *When taken as directed. See Drug Facts Panel. actual size Padagis ® padagis-loratadine-d-carton-image.jpg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 20250303
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

