The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Grain And Wheat (NDC 57955-4127). 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 otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
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Active Ingredients: Adrenalinum 6X, Bryonia alba 6X, Lycopodium clavatum 6X, Natrum muriaticum 6X, Pulsatilla nigricans 6X, Histaminum hydrochloricum 12X, Avena sativa 12X, Glycine max 12X, Hordeum vulgare 12X, Secale cereale 12X, Triticum aestivum 12X, Zea mays 12X.
Uses may help temporarily relieve allergy symptoms •stomach upsets •dry itchy skin •diarrhea •congestion •difficult breathing •rashes
Warnings: Stop and ask a doctor if •symptoms do not impove in 5 days or new symptoms appear •you are a asthma sufferer with severe allergies.
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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: •do not use if printed bottle neck seal is broken or missing •adults and children 12 years and over take 15 drops under the tongue every 3-4 hours 3 times daily •children 2-12 years, take 3-5 drops under the tongue 3 times daily •sensitive persons and asthma sufferers take 1-3 drops and wait 3 hours then continue with regular dosage provided •if allergy or asthma symptoms develop discontinue use.
Other Information: store tightly closed at room temperature (65-80°F).
Other ingredients: purified water, USP alcohol.
Drug Facts
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Active Ingredients Purpose
Adrenalinum 6X.......................................................decongestant
Bryonia alba 6X......................................relieves allergy symptoms
Lycopodium clavatum 6X.........................relieves allergy symptoms
Natrum muriaticum 6X............................relieves allergy symptoms
Pulsatilla nigricans 6X..............................relieves allergy symptoms
Histaminum hydrochloricum 12X................................antihistamine
Avena sativa 12X......................................................allergen (oat)
Glycine max 12X......................................................allergen (soy)
Hordeum vulgare 12X............................................allergen (barley)
Secale cereale 12X....................................................allergen (rye)
Triticum aestivum 12X...........................................allergen (wheat)
Zea mays 12X..........................................................allergen(corn)
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