Label: PAIN RELIEF PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride capsule, coated
- NDC Code(s): 42507-829-27, 42507-829-49, 42507-829-60
- Packager: HyVee Inc
- 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.
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- Active ingredient (in each gelcap)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mgClose
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 have ever had an allergic reaction to this product or any of its ingredients
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.
- 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
These could be signs of a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 Liver 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetinClose
- Package/Label Principal Display Panel
Compare to Extra Strength Tylenol® PM active ingredients
PAIN RELIEF PM
Night Time Sleep-Aid
- INGREDIENTS AND APPEARANCE
PAIN RELIEF PM EXTRA STRENGTH
acetaminophen, diphenhydramine hcl capsule, coated
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-829 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 28 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 FD&C RED NO. 40 GELATIN HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POVIDONES STEARIC ACID TITANIUM DIOXIDE TRIACETIN Product Characteristics Color BLUE (Dark Blue Opaque) , GRAY, BLUE (Light Blue Opaque) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code L829 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42507-829-27 1 in 1 CARTON 1 80 in 1 BOTTLE 2 NDC:42507-829-49 1 in 1 CARTON 2 40 in 1 BOTTLE 3 NDC:42507-829-60 1 in 1 CARTON 3 20 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 08/02/2010 Labeler - HyVee Inc (006925671)