NIGHT TIME PSEUDO-FREE- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Night Time by

Drug Labeling and Warnings

Night Time by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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, blue 1, citric acid, flavor,
high fructose corn syrup, polyethylene glycol, propylene glycol,
purified water, red 40, saccharin sodium, sodium citrate

Principal Display Panel

Compare to the Active Ingredients in Vicks Nyquil
Premier Value
Cherry Night Time Multi Symptom Cold and Flu Relief
Acetaminophen...Pain Reliever and fever reducer
Dextromethorphan HBr....Cough suppressant
Doxylamine Succinate......Antihistamine
See new dosing and warning information
10 percent alcohol
Premier Value Guarantee
6 fl oz 177mL

Package Label

 

Premier Value Night Time

INGREDIENTS AND APPEARANCE

NIGHT TIME  PSEUDO-FREE
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-113
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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Nyquil Type Cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-113-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/13/2010

Labeler - Chain Drug Consortium, LLC (101668460)