Label: EXTRA STRENGTH PAIN RELIEVER PM- acetaminophen and diphenhydramine hydrochloride capsule
- NDC Code(s): 21130-556-31
- Packager: Safeway
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
If you are a consumer or patient please visit this version.
- Active ingredients (in each gelcap)
Acetaminophen 500 mgClose
Diphenhydramine HCl 25 mg
temporary relief of occasional headaches and minor aches and pains with 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 product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- liver disease
- 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 beverages
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 gelcaps at bedtime
- do not take more than 2 gelcaps of this product in 24 hours
- children under 12 years: do not use
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- see end flap for expiration date and lot number
- Inactive ingredients
ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to Extra Strength Tylenol® PM active ingredients*
Pain Reliever PM
Acetaminophen, 500 mg
Diphenhydramine HCl, 25 mg
• Pain Reliever/Nighttime Sleep Aid
• Rapid Release Gels
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Extra Strength Tylenol® PM .
DISTRIBUTED BY SAFEWAY INC., P.O. BOX 99
PLEASANTON, CA 94566-0009
QUALITY & SATISFACTION GUARANTEED OR
YOUR MONEY BACK
1-888-SAFEWAY / www.safeway.com
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEVER PM
acetaminophen and diphenhydramine hcl capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-556 Route of Administration ORAL DEA Schedule 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 RED NO. 3 (UNII: PN2ZH5LOQY) HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 21mm Flavor Imprint Code L;6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-556-31 1 in 1 CARTON 1 80 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/17/2007 Labeler - Safeway (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(21130-556) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(21130-556)