0752-Rugby
Drug Labeling and Warnings
Drug Details [pdf]
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE- acetaminophen, diphenhydramine hydrochloride tablet, film coated
Rugby Laboratories
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.
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0752-Rugby
Uses
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
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away
Do not use
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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
- glaucoma
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.
Directions
- 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
croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin
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
www.rugbylaboratories.com
*Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®.
COMPARE TO THE ACTIVE INGREDIENTS IN EXTRA STRENGTH TYLENOL ® PM*
Rugby ®
NDC: 0536-1173-06
See New Warnings Information & Directions
Acetaminophen 500 mg & Diphenhydramine HCI 25 mg
Pain Rekiever/ Sleep Aid
50 Caplets
| ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
acetaminophen, diphenhydramine hydrochloride tablet, film coated |
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| Labeler - Rugby Laboratories (079246066) |
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