FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE FORMS & STRENGTHS
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Amz789 Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Diphenhydramine HCl 25 mg
Dosage & Administration
Diphenhydramine HCl 25 mg
Otc - Purpose
Nighttime sleep-aid
Indications & Usage
for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep
Warnings
Warnings
Otc - Do Not Use
- 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
- do not use with NyQuil
Otc - Ask Doctor/Pharmacist
- a breathing problem such as asthma, emphysema, or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid
Otc - When Using
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage Forms & Strengths
take only one dose per day (24 hours) - see Overdose warning
adults & Children 12 yrs & over | One dose = TWO 25mg softgels (50mg) at bedtime if needed or as directed by a doctor |
Inactive Ingredient
FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink
Package Label.Principal Display Panel
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