Label: PAIN RELIEF PM EXTRA STRENGTH- acetaminophen and diphenhydramine hcl tablet
- NDC Code(s): 21130-556-09, 21130-556-31
- Packager: Better Living Brands, LLC
- 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 31, 2016
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- 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the 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
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 take more than directed
- 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
Pain Relief PM
ACETAMINOPHEN, 500 mg
Diphenhydramine HCl, 25 mg
Pain Reliever - Nighttime Sleep Aid
• Aspirin free
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Extra Strength Tylenol® PM.
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
QUALITY & SATISFACTION
OR YOUR MONEY BACK.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Signature Care 44-556
- INGREDIENTS AND APPEARANCE
PAIN RELIEF PM EXTRA STRENGTH
acetaminophen and diphenhydramine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-556 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 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 OVAL Size 20mm Flavor Imprint Code L;6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-556-09 1 in 1 CARTON 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:21130-556-31 1 in 1 CARTON 2 80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 12/17/2007 Labeler - Better Living Brands, LLC (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)