NDC | 68016-730-08 |
Set ID | 79d0f7e5-c32e-4065-9638-ce87b8ff9b97 |
Category | Human OTC Drug Label |
Packager | Chain Drug Consortium, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Drug Facts
- Purpose
- Uses
-
Warnings
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
- blisters
- rash.
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
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
- for 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
- Ask a doctor or pharmacist before use if you are
- When using this product
-
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.
- If pregnant or breast-feeding,
-
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 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.
-
Directions
- do not take more than directed (see overdose warning)
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- mL = milliliter
adults and children 12 years and over - take 30 mL at bedtime
- do not take more than 30 mL in 24 hours
children under 12 years do not use - Other information
- Inactive ingredients
- Questions or comments?
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)
NDC 68016-730-08
Compare to the active ingredients in TYLENOL® PM tablet*
SEE WARNINGS INFORMATIONPremier Value®
Nighttime
Pain Plus Sleep
Acetaminophen 500 mg,Diphenhydramine HCl 25 mg
Pain Reliever, Nighttime Sleep Aid
Berry
(Alcohol free)
8 FL OZ
(237 mL)
Do not use if printed shrinkband is missing or broken.
-
INGREDIENTS AND APPEARANCE
PAIN AWAY PLUS SLEEP AID
acetaminophen, diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-730 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) PEPPERMINT (UNII: V95R5KMY2B) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color BLUE (blue to bluish green) Score Shape Size Flavor BERRY, PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-730-08 1 in 1 CARTON 07/24/2015 07/01/2022 1 237 mL in 1 BOTTLE; 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 07/24/2015 07/01/2022 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(68016-730)