Label: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE tablet
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 28, 2011
If you are a consumer or patient please visit this version.
- Drug Facts
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 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 product containing diphenhydramine, even one used on skin ■ in children under 12 years of age ■ 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; ■ trouble urinating due to an enlarged 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 serious underlying medical illness. ■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days ■ redness or swelling is present
■ new symptoms occur
These could be signs of a serious condition.
- Overdasage Warnings;
- Directions: do not take more than directed (see overdose warning)
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
acetaminophen and diphenhydramine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52204-124 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color BLUE (Blue) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code C;24 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52204-124-99 24390 in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/28/2011 Labeler - Cispharma, Inc (833171445) Registrant - Cispharma, Inc (833171445) Establishment Name Address ID/FEI Business Operations Cispharma, Inc 833171445 manufacture