ACETAFLU NIGHTTIME EFFERVESCENT- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, effervescent 
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals

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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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

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
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.
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.

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

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

Inactive ingredients

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

dimethicone

Product Label

image description

ACETAFLU NIGHTTIME EFFERVESCENT 
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-841
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeROUND (TABLET) Size3mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13411-841-164 in 1 BOX03/24/2020
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/24/2020
Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)
Establishment
NameAddressID/FEIBusiness Operations
S.P.M CORPORATION555279715manufacture(13411-841)

Revised: 3/2020
Document Id: 106498d1-31cc-41e7-a17b-9463fbeb6cb1
Set id: d5ebda54-8917-4bd7-af47-354432f13cc8
Version: 1
Effective Time: 20200326
 
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals