ACETAFLU COUGH AND CHEST CONGESTION- dextromethorphan hbr,guaifenesin powder

ACETAFLU COUGH AND CHEST CONGESTION by

Drug Labeling and Warnings

ACETAFLU COUGH AND CHEST CONGESTION 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 Ingredients

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes

• Cough suppressant
• Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
•  helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Do not use

•  in a child under 12 years of age
•  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

•  cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
• a sodium-restricted diet

When using this product

• do not exceed recommended dosage

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back or occurs with fever, rash, or headache that lasts. These could be signs of a 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.

Directions

do not use more than directed
take every 4 hours. Do not take more than 6 packets in 24 hours.

• Age: Dose
• adults and children 12 years of age and over: one packet
• children under 12 years of age: do not use

• dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
• if using 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: potassium 12 mg, sodium 51 mg.
• store at controlled room temperature 20-25°C (68-77°F).

Inactive Ingredients.

acesulfame potassium, anhydrous citric acid, flavor, lactose, maltodextrin, mannitol, povidone K30, silicon dioxide, sodium bicarbonate, sodium chloride, sodium citrate, sucralose, sucrose

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAFLU COUGH AND CHEST CONGESTION 
dextromethorphan hbr,guaifenesin powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13411-852
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 g
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 5 g

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13411-852-06	6 in 1 BOX	08/31/2020
1		5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 13411-852-12	12 in 1 BOX	08/31/2020
2		5 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 13411-852-20	20 in 1 BOX	08/31/2020
3		5 g in 1 PACKET; 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	08/31/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
S.P.M CORPORATION		555279715	manufacture(13411-852)