Active Ingredient (In Each Capsule)
Diphenhydramine HCl 25 mg
Allergy Relief Capsule
FDA Label NDC 70000-0771
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Allergy Relief (NDC 70000-0771). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
• temporarily relieves these symptoms due to hay fever or upper respiratory allergies:
• runny nose • sneezing
• itchy, watery eyes • itching of the nose or throat
• temporarily relieves these symptoms due to the common cold:
• runny nose • sneezing
Warnings
Do not use
• to make a child sleepy
• with other products containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 times in 24 hours
adults and children 12 years and older | 1 to 2 capsules |
| children 6 to under 12 years old | 1 capsule |
| children under 6 years old | do not use |
Other Information
• store at 20 – 25°C (68–77°F)
• protect from light, heat and moisture
Inactive Ingredients
butylparaben, D&C red no. 28, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate-80, propylparaben, purified water, sodium lauryl sulphate, starch
Questions Or Comments?
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Packaging
Leaderallergy Relief (700000771 2)
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