Sulisrx Pain Reliever Anti-Histamine
Drug Facts - Tablets
The following Structured Product Label (SPL) was submitted to the FDA by Sephoris Pharmaceuticals, Llc for the product Sulisrx Sunburn Relief Kit (NDC 87735-003). 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 sulisrx pain reliever anti-histamine, otc - active ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts - Tablets
Active Ingredients (in each tablet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2mg
Active Ingredient
Lidocaine 2%
Purposes
Pain reliever / fever reducer
Antihistamine
Pain reliever & antihistamine
Purpose
External Analgesic
Uses
Uses
Temporarily relieves pain and itching due to
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions.
If a skin reaction occurs, stop use and seek medical help right away.
Warnings
For external use only
Do not use
As a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
When using this product
Stop use and ask a doctor if
Stop use and ask a doctor if
If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breastfeeding, 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. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Keep out of reach of children
Directions
Directions
Other information
Other information
Inactive ingredients:
Colloidal silicon dioxide, FD&C; Blue No. 2 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
Inactive ingredients:
Alcohol, Caprylyl Glycol, Disodium EDTA, Ethylhexylglycerin, Hexylene Glycol, Lactic Acid, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Hydroxide, Sodium Lactate, Strontium CHloride Hexahydrate
Drug Facts - Lidocaine Spray
Questions or comments?
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Distributed by
Sephoris Pharmaceuticals, LLC, San Diego, CA 92121
Contains: 1 topical 2% Lidocaine HCL spray and 24 pain relief/antihistamine tablets
SULISRx
SUNBURN RELIEF KIT
Fast Acting
Cools & Soothes Skin
Fast Pain & Itch Relief
With 2% Lidocaine HCL
Contains: 1 topical spray and 24 tablets
* Please review the disclaimer below.