NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Cellchem Pharmaceuticals Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- Temporarily relief of these cold and flue sysmptoms: nasal and sinus congestion   sore throat pain headache body aches and pains runny nose sneezing - nasal and sinus congestion   - sore throat pain - headache - body aches and pains - runny nose - sneezing - Temporarily relief of dry cough - Reduce fever Cold and flue sysmptoms: - nasal and sinus congestion - sore throat pain - headache - body aches and pains - runny nose - sneezing
Authorization status:
OTC monograph final
Authorization number:
73147-3109-6

NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF- acetaminophen, diphenhydramine

hydrochloride, phenylephrine hydrochloride powder

Cellchem Pharmaceuticals Inc

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.

----------

Nighttime

Severe cold cough & flu relief

Nighttime

Severe cold cough & flu relief

Active Ingredients (in each pouch) Purpose

Acetaminophen (Extra Strength) 650 mg..................Pain reliever/Fever reducer

Diphenhydramine Hydrochloride 25 mg............Antihistamine/ Cough Suppressant

Phenylephrine Hydrochloride 10 mg......................................Nasal decongestant

Us es

Temporarily relief of these cold and flue sysmptoms:

nasal and sinus congestion

sore throat pain

headache

body aches and pains

runny nose

sneezing

Temporarily relief of dry cough

Reduce fever

Cold and flue sysmptoms:

nasal and sinus congestion

sore throat pain

headache

body aches and pains

runny nose

sneezing

Warnings

Liver warning

Acetaminophen may cause severe or possibly fatal liver damage if you take:

more than the recommended dose in 24 hours

with other drugs containing acetaminophen

while drinking 3 or more alcoholic drinks every day

Symptoms of liver damage may include:

yellow skin or eyes

dark urine

sweating

nausea

vomiting

stomach pain

unusual tiredness

loss of appetite

Allergy alert

Acetaminophen may cause serious skin reactions. Symptoms may include:

skin reddening

blisters

rash

If any of these symptoms occur, stop use and seek medical help right away.

Do not use

in children under 12 years

if you are allergic to acetaminophen, phenylephrine or any other ingredient in this product

with any other drug containing acetaminophen, phenylephrine. 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 the skin

with a monoamine oxidase inhibitor (MAOI) (drugs for depression or Parkinson’s disease) or for 2

weeks after stopping the MAOI drug

with other cough and cold medications.

Ask a doctor or pharmacist before use if you

have:

heart, liver, kidney or thyroid disease

high blood pressure

diabetes

glaucoma

trouble urinating

breathing problem such as emphysema or chronic bronchitis

take:

the blood thinning drug warfarin

sedatives or tranquilizers

are pregnant or breastfeeding

When using this product

drowsiness may occur

alcohol, sedatives and tranquilizers may increase drowsiness

do not drive or engage in activities requiring alertness

avoid alcoholic drinks

excitability may occur, especially in children

Stop use and ask a doctor if

symptoms worsen or last more than 7 days, or you have a fever (>38ºC)

pain lasts more than 5 days

fever lasts more than 3 days

sore throat pain lasts more than 2 days

you are:

nervous

dizzy

can’t sleep

Keep out of reach of children.

In case of overdose, call a Poison Control Centre or get medical help right away. Quick medical

attention is critical even if you do not notice any signs or symptoms

Directions

Adults and children 12 years and over:

dissolve contents of 1 pouch in 225 mL (1 cup) of boiling water

may be taken every 4 to 6 hours

do not take more than 4 pouches in 24 hours (see Liver warning)

Other Information

Store at 15-30°C in a dry place

Inactive ingredients

Acesulfame potassium, aspartame (contains phenylalanine), caramel color, citric acid, D&C Yellow No.

10, flavors, maltodextrin, sodium citrate, starch and sucrose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF

acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73147-310 9

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

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

ASPARTAME (UNII: Z0 H242BBR1)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

STARCH, CO RN (UNII: O8 232NY3SJ)

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

yello w (D and C Yello w 10 )

S core

S hap e

S iz e

Flavor

HONEY (ho ney lemo n infused with white tea flavo rs)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:73147-310 9 -

10 in 1 BOX, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/0 1/20 19

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 7/0 1/20 19

Cellchem Pharmaceuticals Inc

Labeler -

Cellchem Pharmaceuticals Inc (111518618)

Registrant -

Cellchem Pharmaceuticals Inc (111518618)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Labo rato ires Co nfab Inc

241754217

ma nufa c ture (73147-310 9 )

Revised: 8/2019

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