ACETAFLU NIGHTTIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl powder 
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 packet)                                                                   Purposes

Acetaminophen 650 mg............................................................................Pain reliever/fever reducer
Diphenhydramine 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
• runny nose • sneezing • itchy nose or throat • itchy, watery eyes due to hay fever
• 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 packets 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 • glaucoma
• a sodium-restricted diet • trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema, asthma or chronic bronchitis
• 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
• sedatives or tranquilizers • the blood thinning drug warfarin

When using this product
• do not exceed recommended dosage • avoid alcoholic drinks • marked drowsiness may occur
• alcohol, sedatives and tranquilizers 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 use more than directed
• take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor

  Age                                                                                      Dose

children under 4 years of age                                          do not use

children 4 to under 12 years of age                                  do not use unless directed by a doctor

adults and children 12 years of age and over                    one packet

Do not overheat.

Other Information

Inactive ingredients

sodium citrate, mannitol, aspartame, hydroxypropyl cellulose, citric acid, tween 80, acesulfame potassium, flavors, sodium bicarbonate

Product Label

image description

ACETAFLU NIGHTTIME 
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-839
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 2 g
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 2 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg  in 2 g
Inactive Ingredients
Ingredient NameStrength
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
MANNITOL (UNII: 3OWL53L36A)  
ASPARTAME (UNII: Z0H242BBR1)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13411-839-066 in 1 BOX03/24/2020
12 g in 1 PACKET; 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(13411-839)

Revised: 3/2020
Document Id: 4d88b4d2-f3db-441c-aabb-fe0939f0c993
Set id: 38523061-404b-43fe-b05a-41ff92f550b5
Version: 1
Effective Time: 20200326
 
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals