PANADOL (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed
Generic: acetaminophen and 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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Active Ingredients (in Each Caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purposes
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 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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 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.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking
- the blood thinning drug warfarin
- sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptoms appear
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:
Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed(see overdose warning)
- adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
- do not give to children under 12 years of age
Other Information
- store below 25°C (77°F)
Inactive Ingredients
carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Questions Or Comments?
1-800-455-7139
Principal Display Panel
NDC 0135-0608-01
PANADOL
EXTRA STRENGTH
PM
ACETAMNOPHEN
Pain Reliever
DIPHENHYDRAMINE HCl
Nighttime Sleep-Aid
24 CAPLETS
Tamper-Evident Feature:Do not use if printed bottle seal (under cap) is missing or broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSKConsumer Healthcare, Warren, NJ 07059
©2016 GSK group of companies or its licensor.
101639XE
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