ACETAFLU NIGHTTIME EFFERVESCENT- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, effervescent

AcetaFlu NightTime Effervescent by

Drug Labeling and Warnings

AcetaFlu NightTime Effervescent by is a Otc medication manufactured, distributed, or labeled by Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals, S.P.M CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet)                                                                         Purposes

Acetaminophen 650 mg.................................................................................Pain reliever/fever reducer
Diphennhydramine Hydrochloride 25 mg.........................................................Antihistamine/ Cough suppressant
Phenylephrine Hydrochloride 10 mg................................................................Nasal decongestant

PURPOSE

INDICATIONS & USAGE

Uses
temporarily relieves these symptoms due to a cold:
minor aches and pains minor sore throat pain headache
nasal and sinus congestion cough due to minor throat and bronchial irritation
temporarily reduces fever

WARNINGS

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 6 tablets 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 in a child under 12 years of age if you are allergic to acetaminophen
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.

Ask a doctor before use if you have
liver disease heart disease high blood pressure thyroid disease diabetes
trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage. avoid alcoholic drinks marked drowsiness may occur.

Alcohol, sedatives and tranquilizes may increase drowsiness be careful when driving a motor vehicle or operating machinery

excitability may occur, especially with children.

Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days
redness or swelling is present new symptoms occur symptoms do not get better or worsen
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with fever, rash or headache that lasts. These could be signs or serious condition.

If pregnant or breast-feeding, ask a health care professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is
critical for adults as well as children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions
do not take more than the the recommended dose
adults and children 12 years and over: take 1 tablet fully dissolved in 8 oz of water every 4 hours. Do not exceed 6 tablets in 24 hours or as directed by a doctor
children under 12 years: do not use

SPL UNCLASSIFIED SECTION

Other information
each tablet contains: sodium 272 mg
store at room temperature. Avoid excessive heat .

INACTIVE INGREDIENT

Inactive ingredients

mannitol, aspartame, kollidon 30, citric acid, tween 20, sodium citrate, sodium bicarbonate, sodium carbonate, flavors, polyethylene glycol,

dimethicone

Product Label

INGREDIENTS AND APPEARANCE

ACETAFLU NIGHTTIME EFFERVESCENT 
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13411-841
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)
ASPARTAME (UNII: Z0H242BBR1)
POVIDONE K30 (UNII: U725QWY32X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
DIMETHICONE (UNII: 92RU3N3Y1O)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (TABLET)	Size	3mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13411-841-16	4 in 1 BOX	03/24/2020
1		4 in 1 BLISTER PACK; 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	03/24/2020

Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)

Establishment
Name	Address	ID/FEI	Business Operations
S.P.M CORPORATION		555279715	manufacture(13411-841)