Dosage & Administration
reduces withdrawal symptoms, including nicotine craving, associated withquitting smoking
Nicotine Oral Pouch Lozenge
FDA Label NDC 87494-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Shuimu Jiahe Trading Co., Ltd. for the product Nicotine Oral Pouch (NDC 87494-001). 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 dosage & administration, inactive ingredient, otc - active ingredient, otc - ask doctor, otc - keep out of reach of children, otc - purpose, warnings, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Microcrystalline cellulose, mannitol, propylene glycolsodium chloride, sodium bicarbonate, acesulfame, edible essence.
Otc - Active Ingredient
Nicotine (8 mg per pouch)
Otc - Ask Doctor
Ask a doctor or pharmacist before use if you are: Using a non-nicotine stopsmokindrug. Taking a prescription medicine for depression or asthma. Yourprescription dose may need to be adiusted.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - Purpose
Stop smoking aid
Warnings
If you are pregnant or breast-feeding, only use this medicine on the advice ofyour health care provider. smoking can seriously harm your child. Try to stopsmoking without using any nicotine replacement medicine. This medicine isbelieved to be safer than smoking. However, the risks to your child from thismedicine are not fully known.
Indications & Usage
To use, place one pouch between your gum and lip. Leave it in place. Do not chewor swallow the pouch.
-You may feel a slight tingling sensation.-Do not eat or drink 15 minutes before using or while the pouch is in your mouth,to maximize the experience.
-lf you are using this product to change your habits, using at least a certainnumber of pouches per day initially may help manage urges.-Do not use more than one pouch at a time or continuously use one pouch afteranother, as this may cause hiccups, heartburn, nausea, or other side effects.-Do not exceed your personal tolerance. lt is recommended to start slowly andassess your response.
-Do not use more than 6 pouches in 5 hours. Do not use more than 20 pouches perday.
-lt is important to be mindful of your usage. lf you feel you need to use the pouchfor a longer period to manage your habits, consider consulting your health careprovider for a plan.
Package Label.Principal Display Panel
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