ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG (diphenhydramine hydrochloride 25 mg acetaminophen 500 mg) Dailymed
Generic: acetaminophen / diphenhydramine
IMPRINT: AP 133
SHAPE: oval
COLOR: blue
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Drug Facts
Otc - Active Ingredient Section
Acetaminophen 500 mg
Diphenhydramine HCL 25 mg
Otc - Purpose Section
Pain reliever
Nighttime sleep aid
Indications & Usage Section
temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings Section
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Other Safety Information
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- bulers
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Otc - Do Not Use Section
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If ypu are not sure whether a drug contains acetaminophen, ask doctor or pharmacist.
- with any other drug containing diphenhydramine, even one used on skin
- in children under 12 years of age
Otc - Ask Doctor Section
Ask a doctor before use if you have
- liver disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Drug Facts continued on back of label
Otc - Ask Doctor/pharmacist Section
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Otc - When Using Section
When using this product
- marked drowsiness will occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase droqsiness
- do not drive a motor vehicle or operate machinery
Otc - Stop Use Section
Stop use and ask a doctor if
- sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Incase of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over:
- take 2 caplets at bedtime if needed
- do not take more than directed
children under 12 years: do not use
Other Information
store at room temperature 15º-30ºC (59º-86ºF)
Inactive Ingredient Section
croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide
Otc - Questions Section
call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol® PM
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
www.reliable1labs.com
Package Label.principal Display Panel
NDC 69618-013-05
Acetaminophen 500 mg & Diphenhydramine HCL 25 mg
PAIN RELIEVER
NIGHTTIME SLEEP AID
50 CAPLETS
*Compare to Active Ingredients in Tylenol® PM
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