Label: PAIN RELIEF PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet
- NDC Code(s): 41163-214-10, 41163-214-50
- Packager: SuperValu (Equaline)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 4, 2013
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- Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mgClose
Temporary relief of occasional headaches and minor aches and pains accompanying sleeplessnessClose
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 every day 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 products containing diphenhydramine, even one used on skin
- in children under 12 years of age
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
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.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see overdose warning)
- 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
- store at room temperature 15o- 30o C (59o- 86o F)
- avoid high humidity and excessive heat
- Inactive ingredients
croscarmellose sodium*, D&C Yellow #10 Aluminum Lake*, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake*, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*
*contains one or more of these ingredientsClose
- Questions or comments?
Call toll free 1-877-932-7948Close
- Principal Display Panel
Compare to Extra Strength TYLENOL® PM Caplets active ingredients**
Pain Relief PM
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
Pain reliever/ Nighttime Sleep Aid
Non Habit forming
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGClose
- Product Label
Pain Relief PM Caplets
- INGREDIENTS AND APPEARANCE
PAIN RELIEF PM EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-214 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM SILICATE (UNII: 9B9691B2N9) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code S525;CPC752 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-214-10 1 in 1 BOX 1 100 in 1 BOTTLE 2 NDC:41163-214-50 1 in 1 BOX 2 50 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part338 03/25/2013 Labeler - SuperValu (Equaline) (006961411) Registrant - P and L Development of New York Corporation (800014821)