Rugby Acetaminophen 500 mg and Diphenhydramine HCl 25 mg Pain Reliever/Sleep Aid
Medically reviewed on June 27, 2017
Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: RUGBY LABORATORIES
NDC Code: 0536-1015
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredients (in each Captab)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Nighttime Sleep Aid
Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
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
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.
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist 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 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
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
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 overdose, get medical help or contact a Poison Control Center right away (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.
- Do not take more than directed (see overdose warning)
Adults and children 12 years and over: Take 2 captabs at bedtime. Do not take more than 2 captabs of this product in 24 hours
Children under 12 years: do not use
- Store at room temperature
Inactive ingredients Croscarmellose sodium, crospovidone, FD&C blue #1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silica, sodium starch glycolate, stearic acid and titanium dioxide.
Questions or comments? Call 1-800-645-2158
Do not use if imprinted safety seal under cap is broken or missing
Distributed by: Rugby Laboratories
17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152
COMPARE TO ACTIVE INGREDIENTS IN EXTRA STRENGTH Tylenol® PM*
See New Warnings Information & Directions
Acetaminophen 500 mg and Diphenhydramine HCl 25 mg
Pain Reliever / Sleep Aid
* Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®
|RUGBY ACETAMINOPHEN 500 MG AND
DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID
acetaminophen,diphenhydramine hcl tablet, film coated
|Labeler - RUGBY LABORATORIES (079246066)|
|Registrant - GEMINI PHARMACEUTICALS INC. (055942270)|
|GEMINI PHARMACEUTICALS INC.||055942270||manufacture(0536-1015)|