NIGHT TIME COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride solution

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Kroger Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant
Authorization status:
OTC monograph final
Authorization number:
30142-949-30

NIGHT TIME COLD AND FLU- acetaminophen, diphenhydramine hydrochloride,

phenylephrine hydrochloride solution

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.

----------

Kroger Co. Night Time Cold & Flu Drug Facts

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purpos es

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Us es

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

temporarily relieves these common cold and flu symptoms:

cough

nasal congestion

minor aches and pains

sinus congestion and pressure

sore throat

headache

runny nose

sneezing

temporarily reduces fever

controls cough to help you get to sleep

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

skin reddening

blisters

If a skin reaction occurs, stop use and seek medical help right away.

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

rash

with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

with any other product containing diphenhydramine, even one used on skin

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.

if you have ever had an allergic reaction to this product or any of its ingredients

liver disease

heart disease

diabetes

high blood pressure

thyroid disease

glaucoma

trouble urinating due to an enlarged prostate gland

a breathing problem such as emphysema or chronic bronchitis

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

cough that occurs with too much phlegm (mucus)

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

do not use more than directed

excitability may occur, especially in children

marked drowsiness may occur

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic drinks

be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: 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

Other information

Inactive ingredients

anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C blue #1, FD&C red #40, flavor,

glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution,

sucralose, triethyl citrate, xanthan gum

Questions or comments?

1-800-632-6900

Package/Label Principal Display Panel

COMPARE TO the active ingredients of MUCINEX FAST-MAX NIGHT TIME COLD & FLU

See back panel

nervousness, dizziness or sleeplessness occur

pain, nasal congestion, or cough gets worse or lasts more than 7 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back or occurs with rash or headache that lasts. These could be signs of a serious

condition.

do not take more than directed (see Overdose warning)

do not take more than 5 doses in any 24-hour period

measure only with dosing cup provided

do not use dosing cup with other products

dose as follows or as directed by a doctor

adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours

children under 12 years of age: do not use

each 20 mL contains: sodium 7 mg

store at 20-25 C (68-77 F)

dosing cup provided

do not refrigerate

for ages 12+

OUR PHARMACIST RECOMMENDED

Maximum Strength

FAST NIGHTTIME

Cold & Flu

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

1 FOR ALL RELIEF

NASAL CONGESTION

SNEEZING, RUNNY NOSE

ACHES, HEADACHE

COUGH, ITCHY THROAT

6 FL OZ (180 mL)

NIGHT TIME COLD AND FLU

acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:30 142-9 49

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

6 50 mg

in 20 mL

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 )

(DIPHENHYDRAMINE - UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

in 20 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

in 20 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

BLUE

S core

S hap e

S iz e

Flavor

FRUIT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:30 142-9 49 -30

18 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 5/22/20 19

Kroger Company

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 5/22/20 19

Labeler -

Kroger Company (006999528)

Revised: 4/2020

Similar products

Search alerts related to this product

View documents history

Share this information