Only For (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed
Generic: acetaminophen, diphenhydramine hcl is used for the treatment of Anxiety Disorders Infant, Newborn Infant, Premature Sleep Initiation and Maintenance Disorders Lactation Motion Sickness Nausea Rhinitis, Allergic, Perennial Sneezing Status Asthmaticus Urticaria Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain
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Drug Facts
Active Ingredient (in Each Caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purpose
Pain reliever
Nighttime sleep aid
Uses:
- temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings:
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 1,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
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.
Do not useÂ
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you have ever had any allergic reaction to this product or any of its ingredients
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Ask a doctor before use if you have
• liver disease   • a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland   • glaucoma
Ask a doctor before use if you are
• taking the blood thinning drug warfarin   • taking sedatives or tranquilizers
When using this product
• drowsiness will occur  • avoid alcoholic drinks  • do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
• sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.   • pain gets worse or lasts more than 10 days
• fever gets worse or last more than 3 days   • redness or swelling is present
• new symptoms occur.
These could be signs of a serious condition.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children
Overdose Warning: In case of accidental 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 any signs or symptoms.
Directions:
- take with a full glass of water
- Do not take more than directed (see Overdose Warning)
- do not take more than 2 caplets in 24 hours
adults and children 12 years of age and over
- Â 2 caplets at bedtime
- do not take more than 2 caplets in 24 hours
 children under 12 years of age  do not use
Other Information:
- Store at room temperature between 20-25°C (68-77°F).
Inactive Ingredients:
Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.
Questions Or Comments ?
1-833-665-9444.
NDC: 73006-119-41
Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.
www.onlyfor.com
Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.
Tear along perforation push product through foil
Packaging
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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