Label: ACETAFLU COUGH AND CHEST CONGESTION- dextromethorphan hbr,guaifenesin powder
- NDC Code(s): 13411-852-06, 13411-852-12, 13411-852-20
- Packager: Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated August 31, 2020
If you are a consumer or patient please visit this version.
- Active Ingredients
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.
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
- Inactive Ingredients.
- 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)