SPL v9
SPL
SPL Set ID 344440bc-d810-4296-93ec-e6ae6673856b
Route
ORAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Citric Acid Monohydrate D&c Yellow No. 10 Fd&c Green No. 3 Fd&c Yellow No. 6 Glycerin Polyethylene Glycol 400 Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-09

Description

Drug Facts Active ingredients (in each 30 mL dose cup) Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg 

Purpose

Purpose Pain reliever/fever reducer   Cough suppressant   Antihistamine 


Medication Information

Purpose

Purpose

Pain reliever/fever reducer   Cough suppressant   Antihistamine 

Description

Drug Facts Active ingredients (in each 30 mL dose cup) Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg 

Uses

Uses temporarily relieves cold/flu symptoms:

  • sore throat
  • minor aches and pain
  • runny nose and sneezing
  • cough due to minor sore throat and bronchial irritation
  • headache
  • fever


Warnings

Liver warning:This product contains acetaminophen. Severe liver damage

may occur if you take ● more than 4 doses (30 mL each) in 24 hours, which is

the maximum daily amount for this product ● with other drugs containing

acetaminophen ● 3 or more alcoholic drinks everyday 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.

Directions

Directions

  • take only as recommended-see Overdose warnings
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours



adults and children 12 years and over                     30 mL (2TBSP) 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

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 after 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

Ask A Doctor

Ask 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 prostate gland

Overdose Warning

Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

Other information

  • each 30 mL dose cup contains:
  • sodium 45 mg
  • store at room temperature

Active Ingredients

Drug Facts

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg 

Inactive Ingredients

Inactive ingredients: citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

When Using This Product

When using this product

  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor

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, headache that lasts

Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use

  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin

Pregnant Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children.

Package Label Night Time Cold & Flu Relief

NDC 76281-501-28

AP SAFE

*COMPARE TO

the active ingredients in

VICKS ®NYQUIL ®

Night Time

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Doxylamine Succinate – Antihistamine

Multi-Symptom

Cold & Flu Relief

Original Flavor

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

*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 08110

12 OZ

6 OZ

res


Structured Label Content

Uses

Uses temporarily relieves cold/flu symptoms:

  • sore throat
  • minor aches and pain
  • runny nose and sneezing
  • cough due to minor sore throat and bronchial irritation
  • headache
  • fever


Purpose

Purpose

Pain reliever/fever reducer   Cough suppressant   Antihistamine 

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage

may occur if you take ● more than 4 doses (30 mL each) in 24 hours, which is

the maximum daily amount for this product ● with other drugs containing

acetaminophen ● 3 or more alcoholic drinks everyday 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.

Directions

Directions

  • take only as recommended-see Overdose warnings
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours



adults and children 12 years and over                     30 mL (2TBSP) 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

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 after 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

Ask A Doctor

Ask 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 prostate gland

Overdose Warning

Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

Other information

  • each 30 mL dose cup contains:
  • sodium 45 mg
  • store at room temperature

Active Ingredients

Drug Facts

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg 

Inactive Ingredients

Inactive ingredients: citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

When Using This Product

When using this product

  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor (Stop Use And Ask A Doctor)

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, headache that lasts

Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use

  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin

Pregnant Or Breast Feeding (Pregnant Or Breast-Feeding)

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children.

Package Label Night Time Cold & Flu Relief (Package Label - Night Time Cold & Flu Relief)

NDC 76281-501-28

AP SAFE

*COMPARE TO

the active ingredients in

VICKS ®NYQUIL ®

Night Time

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Doxylamine Succinate – Antihistamine

Multi-Symptom

Cold & Flu Relief

Original Flavor

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

*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 08110

12 OZ

6 OZ

res


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)