Sleep Aid by Topco Associates, LLC
Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Topco Associates, LLC
NDC Code: 36800-672
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Diphenhydramine HCl 25 mg
- for relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
- a breathing problem such as asthma, emphysema, or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- heart disease
taking sedatives or tranquilizers or any other sleep aid.
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- use caution when driving a motor vehicle or operating machinery
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- do not take more than directed
- adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
- children under 12 years: do not use
- each caplet contains: calcium 70 mg
- avoid excessive heat (greater than 100°F) or humidity
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
• Non-habit forming
• Not for treating cold or flu
200 CAPLETS - 25 mg EACH
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
diphenhydramine hcl tablet, film coated
|Labeler - Topco Associates, LLC (006935977)|
|LNK International, Inc.||868734088||MANUFACTURE(36800-672), PACK(36800-672)|
|LNK International, Inc.||038154464||PACK(36800-672)|
|LNK International, Inc.||832867837||PACK(36800-672)|
|LNK International, Inc.||967626305||PACK(36800-672)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.