Active Ingredients (In Each Caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Diphenhydramine citrate 38 mg
*NonSteroidal Anti-Inflammatory Drug
The following Structured Product Label (SPL) was submitted to the FDA by Sunascen Therapeutics Llc for the product Mygrin Nighttime (NDC 49467-230). 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 ingredients (in each caplet), purpose, indications and usage, reye's syndrome, allergy alert (aspirin), allergy alert (acetaminophen), liver warning, stomach bleeding warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Diphenhydramine citrate 38 mg
*NonSteroidal Anti-Inflammatory Drug
Pain reliever
Pain reliever
Nighttime sleep-aid
For the temporary relief of occasional headaches, and minor aches and pains, with accompanying sleeplessness
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Aspirin may cause a severe allergic reaction, which may include the following,
Acetaminophen may cause severe skin reactions. Symptoms may include the following,
If a skin reaction does occur, stop use and seek medical help right away.
This product contains acetaminophen. Severe liver damage may occur if you take the following,
This product contains an NSAID, which may cause severe stomach bleeding. The chance of severe stomach bleeding is higher if you
Do not use this product in the following scenarios,
Ask a doctor before using this product if,
Ask a doctor or pharmacist before using this product if you are taking the following,
Stop use of this product and ask a Doctor in the event of the following,
These could be signs of a serious condition
If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of an overdose, seek medical help right away or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of reach of children. In case of an overdose, seek medical help right away or contact a Poison Control Center immediately.
Call Poison Control at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Adults and children 12 years of age and over: take up to 2 caplets at bedtime, with a full glass of water.
Corn Starch, Crospovidone, FD&C Blue #1 Aluminum Lake, Hypromellose, Maltodextrin, Medium Chain Triglycerides, Microcrystalline Cellulose, Polydextrose, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Sodium Sulfate, Stearic Acid, Talc, Titanium Dioxide, Yellow Iron Oxide, Zinc Stearate.
Sunascen Therapeutics LLC
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Sunascen Therapeutics LLC
NDC 49467-230-10
MYGRIN NIGHTTIME
ACETAMINOPHEN, 250 mg
ASPIRIN (NSAID), 250 mg
DIPHENHYDRAMINE CITRATE, 38 mg
Pain Reliever and Sleep-Aid
Non-habit forming
"Helping you turn the face of pain into a grin" ™
100 CAPLETS
TAMPER EVIDENT: DO NOT USE IF THE SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: Sunascen Therapeutics LLC, Rockville MD 20850
© 2018 Sunascen Therapeutics LLC, All rights reserved.
Trademarks are owned by or licensed to Sunascen Therapeutics LLC
Sunascen Therapeutics LLC
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