Severe Nighttime description, usages, side effects, indications, overdosage, supplying and lots more!

Severe Nighttime

CVS Pharmacy

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
CVS Pharmacy, Inc. Severe Nighttime Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • •nasal congestion
  • •sinus congestion and pressure
  • •cough due to minor throat and bronchial irritation
  • •minor aches and pains
  • •headache
  • •fever
  • •sore throat
  • •reduces swelling of nasal passages
  • •temporarily restores freer breathing through the nose
  • •promotes nasal and/or sinus drainage
  • •runny nose and sneezing
  • •cough to help you sleep

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. 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

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is 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.
  • •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
  • •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
  • •diabetes
  • •thyroid disease
  • •high blood pressure
  • •heart disease
  • •trouble urinating due to an enlarged prostate gland
  • •a breathing problem such as emphysema or chronic bronchitis
  • •cough that occurs with too much phlegm (mucus)
  • •glaucoma
  • •persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

  • •taking sedatives or tranquilizers
  • •taking the blood thinning drug warfarin

When using this product

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

Stop use and ask a doctor if

  • •you get nervous, dizzy or sleepless
  • •pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • •fever gets worse or lasts more than 3 days
  • •new symptoms occur
  • •redness or swelling is present
  • •cough comes back or occurs with 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 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

  • •take only as directed – see Overdose warning
  • •use dose cup
  • •do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL (2 TBSP) every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

  • •when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

  • •each 30 mL dose cup contains: sodium 12 mg
  • •store at 20°-25°C (68°-77°F)

Inactive ingredients

butylated hydroxyanisole, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Vicks® NyQuil® Severe

SEVERE

NIGHTTIME

COLD/FLU RELIEF

NASAL DECONGESTANT, PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, ANTIHISTAMINE

Maximum Strength Relief

Acetaminophen – aches, fever, sore throat

Dextromethorphan HBr – cough

Doxylamine Succinate – sneezing, runny nose

Phenylephrine HCl – nasal/sinus congestion & sinus pressure

Alcohol free

12 FL OZ (355 mL)

BERRY FLAVOR

Severe Nighttime

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-763
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 20 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 12.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
sodium phosphate, monobasic
POLYETHYLENE GLYCOLS
propylene glycol
water
saccharin sodium
SUCROSE
XANTHAN GUM

Product Characteristics

Color
RED (clear, dark)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-763-34 237 in 1 BOTTLE
2 NDC:59779-763-40 355 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-12-27


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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