Acetagesic
Drug Labeling and Warnings
Drug Details [pdf]
ACETAMINOPHEN AND DIPHENHYDRAMINE HCL- acetagesic tablet
Rugby Laboratories Inc.
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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Acetagesic
Uses
Temporarily reduces fever and relieves minor aches and pain caused by
- common cold
- headache
- toothache
- muscular aches
- backache
- arthritis
- flu
- premenstrual and menstrual cramps
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult or child 12 years and older takes more than 8 tablets in less than 24 hours which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday while using this product.
- 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 drug containing diphenhydramine, even one used on skin
- Ask a doctor before use if the user has
- 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 the user is.
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- When using this product
- you may get very drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
- 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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- adults and children 12 years & over: take 2 tablets every 4 hours, but not more than 8 tablets in 24 hours
- children under 12 years: do not use
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 (al-lake), hypromellose, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, titanium dioxide.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
100 Tablets
NDC: 0536-3605-01
Rugby
Acetaminophen 325 mg / Diphenhydramine HCl 12.5 mg
Pain Reliever, Fever Reducer, Antihistamine
| ACETAMINOPHEN AND DIPHENHYDRAMINE HCL
acetagesic tablet |
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| Labeler - Rugby Laboratories Inc. (079246066) |
Revised: 9/2019
Document Id: 9586f9c0-b5df-4040-978b-84ff2ddc1398
Set id: e49e69ae-3d87-47e4-b486-cfcc8798e991
Version: 3
Effective Time: 20190911