Active ingredient A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each softgel) Diphenhydramine HCl 25 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 • take only one dose per day (24 hours) adults & children 12 yrs & over 2 softgels at bedtime if needed or as directed by a doctor children under 12 yrs do not use Other information • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F) • protect from light
- adults & children 12 yrs & over
| 2 softgels at bedtime if needed or as directed by a doctor |
- children under 12 yrs
| do not use |
Inactive ingredient A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution Questions or comments? 1-800-719-9260
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.
Uses • for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep
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.
good sense sleep time Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL WATER SORBITOL SORBITAN 052
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.
Package/Label Principal Display Panel Non-Habit Forming Sleep Time Nighttime Sleep-Aid Actual Size Diphenhydramine HCl 25 mg Not For Treating Cold or Flu See Warnings Compare to active ingredient of Vicks ® ZzzQuil® LiquiCaps ® 100% SATISFACTION GUARANTEED 12 Softgels 052C2-sleep-time.jpg
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 you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to an enlargement of the 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 • for 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? 1-800-719-9260
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 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 beverages
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 at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F) • protect from light
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 • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to an enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • avoid alcoholic beverages Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use.