Night Time Original description, usages, side effects, indications, overdosage, supplying and lots more!

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Night Time Original

Duane Reade
Aaron Industries, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Acetaminophen 500 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purposes

Acetaminophen...........................................Pain reliever/fever reducer
Dextromethorphan HBr.....................................................Cough suppressant
Doxylamine succinate...............................................................Antihistamine

Night Time Original Uses

temporarily relieves these common cold/flu symptoms: • minor aches and pains
• headache • muscular aches • sore throat • fever • runny nose and sneezing
• itchy nose or throat • coughs • cough due to minor throat and bronchial irritation
• itchy, watery eyes due to hay fever or other upper respiratory allergies

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur
if you take: • more than 4 doses (8 tablespoonfuls or 120 mL) in 24 hours, which is the
maximum daily amount • with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while using this product
Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high
fever, headache, rash, nausea, and vomiting may be serious. Ask a doctor right away.
Do not use more than 2 days or give to children under 12 years of age unless directed
by a doctor.

Do Not Use

• to make a child sleepy • if you are on a sodium-restricted diet
• 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 two
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.
• with any other drug containing acetaminophen (prescription or non-prescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

• liver disease • glaucoma • breathing problems
• chronic bronchitis • trouble urinating due to enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma or emphysema or if
cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking

• sedatives or tranquilizers • the blood thinning drug warfarin

When using this product

• do not use more than directed (see overdose warning)
• 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

• redness or swelling is present • new symptoms occur
• you get nervous, dizzy or sleepless • fever gets worse or lasts more than 3 days
• pain or cough gets worse or lasts more than 7 days
• 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 this and all drugs out of the reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) could cause
serious health problems, including liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Quick medical
attention is critical for adults as well as for children even if you do not notice any signs
or symptoms.

Directions

• use dosage cup or tablespoon (TBSP)
• take only as recommended (see overdose warning)
• do not exceed 4 doses per 24 hours

age                                                                            dose
adults and children 12 years and over................2 TBSPS (30 ml) every 6 hours
children 4 years to under 12 years.......................do not use unless directed by a doctor
children under 4 years..........................................do not use

• When using Day Time and Night Time products,
carefully read each label to ensure correct dosing.

Other Information

• store at controlled room temperature
• sodium content per tablespoon: 18 mg

Inactive Ingredients

alcohol, citric acid, flavor, green 3,
high fructose corn syrup, polyethylene glycol, propylene glycol,
purified water, saccharin sodium, sodium citrate, yellow 6, yellow 10

Principal Display Panel






Night Time Original

Night Time Original

Acetaminophen,Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67732-212
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
CITRIC ACID MONOHYDRATE
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOL 300
propylene glycol
water
SACCHARIN SODIUM ANHYDROUS
SODIUM CITRATE
FD&C GREEN NO. 3
D&C YELLOW NO. 10
FD&C YELLOW NO. 6

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67732-212-06 177 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-09-21


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