Active ingredient A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each softgel) Diphenhydramine HCl 50 mg
Dosage and administration Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Inactive ingredient A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol**, purified water, sorbitol sorbitan** *contains one or more of these ingredients
Indications and usage A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use for relief of occasional sleeplessness.
Purpose Information about the drug product’s indications for use.
Purpose Nighttime sleep-aid
Spl product data elements Usually a list of ingredients in a drug product.
Sleep Aid Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITAN SORBITOL PROPYLENE GLYCOL P50;A99;D50;AP018
Package label principal display panel The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel COMPARE TO THE ACTIVE INGREDIENT IN UNISOM® SLEEPGELS®* NIGHTTIME SLEEP-AID Diphenhydramine HCL 50 mg Help to Reduce Difficulty Falling Asleep Non-Habit Forming SOFTGELS †This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PARKWAY CHESAPEAKE, VA 23320
Product Label FAMILY WELLNESS Nighttime Sleep-Aid Diphenhydramine HCL 50 mg
Ask doctor Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland
Ask doctor or pharmacist Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Do not use Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin
Keep out of reach of children Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Questions A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Stop use Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
When using Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid alcoholic drinks.
Pregnancy or breast feeding Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Storage and handling Information about safe storage and handling of the drug product.
Other information store between 15-30ºC (59-86ºF)
Warnings Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if 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 avoid alcoholic drinks. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 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 (1-800-222-1222).