Label: PAIN RELIEF PM- acetaminophen pm tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 76168-011-04 - Packager: Velocity Pharma
- 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.
Drug Label Information
Updated August 25, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
-
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
-
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case 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 any signs or symptoms.
do not use
- with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- With any other product containing diphenhydramine, even one used on skin.
- In children under 12 years of age
- With other products containing diphenhydramine, even one used on skin.
ask a doctor before use if you have
- liver disease
- asthma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- galucoma
ask your doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedative or tranquilizers.
When using this product
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery, this product will cause drowsiness
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.
- Keep out of reach of children.
-
Directions
- do not exceed recommended dose
- Adults and children 12 years and over:
- take 2 caplets at bedtime.
- do not take more than 2 caplets of this product in 24 hours.
children under 12 years:
- do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
- Other Information
-
Inactive Ingredients
Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified water, Sodium metabisulfite, Sodium starch glycolate, stearic acid, Titanium Dioxide, Talc
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF PM
acetaminophen pm tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-011 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 131 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76168-011-04 24 in 1 BOTTLE 1 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/05/2012 Labeler - Velocity Pharma (962198409)