NDC | 76281-502-28 |
Set ID | 87c2b823-ed88-44f3-8f6a-df30430b40f3 |
Category | HUMAN OTC DRUG LABEL |
Packager | AptaPharma Inc. |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active Ingredients
- Purpose
- Keep Out Of Reach Of Children
- Uses
-
Warnings
Failure to follow these warnings could result in serious consequences
Warnings
Liver warnings:
This product contains acetaminophen. Sever liver damage may occur if you take *more than 4 doses in 24 hours, which is the maximum daily amount *with other drugs containing acetaminophen *3 or more alcoholic drinks every day while using this product.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
- Ask A Doctor
- Ask A Doctor Or Pharmacist
- When Using This Product
-
Stop Use And Ask A Doctor if
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts
These could be signs of a serious condition.
- Pregnancy Or Breast-Feeding
- Overdose Warning
-
Directions
- take only as recommended-see Overdose warning
- Use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
----------------------------------------------------------------------------------------------------------------------
adults and children 12 years and over 30 mL (2 TBSP) every 6 hours
____________________________________________________________________
children 4 to under 12 years ask a doctor
____________________________________________________________________
children under 4 years do not use
____________________________________________________________________- If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours
- Other Information
- Inactive Ingredients
-
Do Not Use
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
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks afet stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
- to make a child sleepy
-
Package Label - Night Time Multi-Symptom Cherry Flavor
NDC 76281-502-28
AP SAFE
*COMPARE TO
the active ingredients in
VICKS® NYQUIL®Night Time
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Doxylamine Succinate – AntihistamineMulti-Symptom
Cold & Flu ReliefCherry Flavor
12 FL OZ (354 mL)
DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequencesDrug Facts
Active ingredients (in each 30 mL dose cup) Purpose
Acetaminophen 650 mg…………………………………Pain reliever/fever reducer
Dextromethorphan HBr 30 mg………………………….………Cough suppressant
Doxylamine Succinate 12.5 mg……………………………..…………AntihistamineUses temporarily relieves cold/flu symptoms: ■ sore throat ■ headache
■ minor aches and pains ■ fever ■ runny nose and sneezing
■ cough due to minor throat and bronchial irritationWarnings
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.
Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.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 ■ for more than 10 days for pain unless directed by
a doctor ■ for more than 3 days for fever unless directed by a doctor. ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product ■ to make a child sleepyAsk a doctor before use if you have ■ a sodium restricted diet ■ liver disease
■ glaucoma ■ cough that occurs with too much phlegm (mucus)
■ a breathing problem or chronic cough that lasts or as occurs with smoking,
asthma, chronic bronchitis or emphysema
■ trouble urinating due to enlarged prostrate glandAsk a doctor or pharmacist before use ■ if you are taking sedatives or
tranquilizers ■ if you are taking the blood thinning drug warfarinWhen using this product ■ do not use more than directed ■ avoid alcoholic drinks
■ excitability may occur, especially in children ■ marked drowsiness may occur ►Drug Facts (continued)
■ be careful when driving a motor vehicle or operating machinery
■ alcohol, sedatives, and tranquilizers may increase drowsinessStop use and ask a doctor if ■ redness or swelling is present
■ symptoms do not get better within 7 days or are accompanied by a fever
■ fever gets worse or lasts more than 3 days ■ new symptoms occur
■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or
headache that lasts. These could be signs of a serious condition.If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.Overdose Warning: Taking more than the recommended dose (overdose) may
cause liver damage. In case of accidental overdose, get medical help or contact
a Poison Control Center right away. Prompt medical attention is critical for
adults as well as for children even if you do not notice any signs or symptoms.b ■ take only as recommended-see Overdose warning
■ Use dose cup or tablespoon (TBSP) ■ do not exceed 4 doses per 24 hours
■ If taking Night Time at night and Day Time during the day, limit total to 4
doses per 24 hours.adults & children 12 years and over 30 mL (2 TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not useOther information ■ each 30 mL dose cup Made in USA
contains: sodium 45 mg ■ store at room temperature AP-LR-09Inactive ingredients citric acid, FD&C Blue No.1,
FD&C Red No. 40, flavor, glycerin, polyethylene glycol,
propylene glycol, purified water, saccharin sodium, sodium
benzoate, sodium citrate, sucroseQuestions? Call weekdays 1-877-798-5944
*This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark Vicks® NyQuil®.
Manufactured by: AptaPharma Inc.,
1533 Union Ave., Pennsauken, NJ 0811012 oz
6 oz
res
-
INGREDIENTS AND APPEARANCE
NITE-TIME COLD/FLU MEDICINE CHERRY
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-502 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) Product Characteristics Color Score Shape Size Flavor CHERRY (CHERRY FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-502-28 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 2 NDC:76281-502-25 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2018 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-502) , pack(76281-502) , label(76281-502)