ACETAMINOPHEN AND DIPHENHYDRAMINE HCL
-
diphenhydramine hydrochloride and
acetaminophen tablet
Rugby Laboratories Inc.
Acetaminophen 325 mg and Diphenhydramine HCl 12.5 mg
Pain Reliever/Fever Reducer
Antihistamine
Temporarily reduces fever and relieves minor aches and pain caused by
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
Do not use
Ask a doctor before use if the user has
Ask a doctor or pharmacist before use if the user is.
When using this product
Stop use and ask a doctor if
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.
Store at room temperature 15°-30°C (59°-86°F)
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.
Call 1-800-645-2158, 9 am – 5 pm ET, Monday – Friday.
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
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part343 | 06/12/2022 |
Labeler - Rugby Laboratories Inc. (191427277) |
Registrant - Advance Pharmaceutical Inc. (078301063) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Advance Pharmaceutical Inc. | 078301063 | MANUFACTURE |