Label: ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG- acetaminophen / diphenhydramine 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 January 28, 2016
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- OTHER SAFETY INFORMATION
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
Stop use and ask a doctor if
- sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
- PREGNANCY OR BREAST FEEDING
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Incase of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice signs or symptoms.
- Other information
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol® PM
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG
acetaminophen / diphenhydramine tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (Light Blue) Score no score Shape OVAL Size 7mm Flavor Imprint Code AP;133 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69618-013-05 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/01/2015 Labeler - Reliable 1 Laboratories LLC (079718111)