ACETAFLU NIGHTTIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl powder

Drug Details [pdf]

ACTIVE INGREDIENT

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
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
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

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

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 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
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 – 15 minutes.
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating.
Do not overheat.
Other Information
- each packet contains: sodium 20 mg
- store at controlled room temperature 20-25ºC (68-77ºF). Protect from excessive heat and moisture.
INACTIVE INGREDIENT

Inactive ingredients

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

ACETAFLU NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13411-839
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 2 g
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg in 2 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg in 2 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 13411-839-06	6 in 1 BOX	03/24/2020
1		2 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/24/2020

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

Name	Address	ID/FEI	Business Operations
Establishment
S.P.M CORPORATION		555279715	manufacture(13411-839)

ACETAFLU NIGHTTIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl powder

AcetaFlu NightTime by

Drug Labeling and Warnings

Drug Details [pdf]