FDA Label for Riteaid Nighttime Sleep Aid
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 354 ML BOTTLE
Riteaid Nighttime Sleep Aid Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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.
Other
Drug Facts
Active Ingredients (In Each 30 Ml)
Acetaminophen 1000 mg
Diphenhydramine HCl 50 mg
Purpose
Pain reliever
Nighttime sleep-aid
Uses
▪ for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
▪ adult takes more than 4 doses (30 mL each) in 24 hrs., which is the maximum daily amount for this product▪ taken with other drugs containing acetaminophen▪ 3 or more alcoholic drinks every day while using this product▪ skin reddening▪ blisters▪ rash
Allergy Alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
Otc - Do Not Use
Do not use
▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.▪ for children under 12 years of age▪ with any other product containing diphenhydramine, even one used on skin.
Otc - Ask Doctor
Ask a doctor before use if you have
• liver disease• a breathing problem such as emphysema or chronic bronchitis• glaucoma• difficulty in urination due to enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin• taking sedatives or tranquilizers
Otc - When Using
When using this product
• avoid alcoholic beverages• drowsiness will occur• do not drive a motor vehicle or operate machinery
Otc - Stop Use
Stop use and ask a doctor if
• pain gets worse or lasts more than 10 days• fever gets worse or lasts more than 3 days• new symptoms occur• Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
These could be signs of a serious condition.
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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
▪ take only one dose (30 mL) per day (24 hours)▪ Only use dose cup provided
adults & children 12 yrs & over | 30 mL at bedtime |
children under 12 yrs | do not use |
Other Information
▪ each 30 mL contains: sodium 10 mg▪ store at room temperature▪ very low sodium
Inactive Ingredients
citric acid, flavors, FD&C Blue No. 1, FD&C Red No. 40, glycerin, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose.
Questions Or Comments?
1-866-467-2748
Principal Display Panel - 354 Ml Bottle
Compare to the active ingredient in Vicks® ZzzQuil™ Night Pain Sleep-Aid*
NDC# 11822-8791-1
Nighttime Sleep-Aid
Pain Reliever
Diphenhydramine HCl
Acetaminophen
• Fall Asleep Fast• Max Strength Pain Reliever• Non-Habit Forming
Berry Flavor
Naturally and Artificially Flavored
No Added Alcohol
12 FL. OZ. (354 ml)
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® ZzzQuil™ Nigh Pain Sleep-Aid.
Distributed by:
* Please review the disclaimer below.