NITETIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, pseudoephedrine hydrochloride liquid 
Kroger Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Kroger Co. Nite Time Drug Facts

Active ingredient (in each 15 mL tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Pseudoephedrine HCl 30 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat and bronchial irritation
nasal congestion
sore throat
headache
minor aches and pains
fever
runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe 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.

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 before use if you have

liver disease
heart disease
thyroid disease
diabetes
glaucoma
high blood pressure
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
cough that lasts or is chronic as occurs with smoking, asthma or emphysema
a sodium-restricted diet

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

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

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.

Directions

take only as recommended – see Liver warning
use dose cup
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

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

Other information

each TBSP contains: sodium 18 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-800-632-6900

Principal Display Panel

Compare to active ingredients of Vicks® NyQuil® D See back panel

Alcohol 10%

See New Warnings Information

Multi-Symptom Cold/Flu Relief

Nite Time

Pain Reliever/Fever Reducer - Acetaminophen

Cough Suppressant - Dextromethorphan HBr

Antihistamine - Doxylamine succinate

Nasal Decongestant - Pseudoephedrine HCl

Aches/Fever/Cough

Sneezing/Runny Nose

Nasal Congestion

Original Flavor

Nite Time Label

Nite Time Label

Nite Time Label

NITETIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-609
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorGREEN (Bright Green) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-609-38295 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/199403/28/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/09/199403/28/2013
Labeler - Kroger Company (006999528)

Revised: 11/2017
 
Kroger Company