Label: ACETAFLU NIGHTTIME EFFERVESCENT- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, effervescent
- NDC Code(s): 13411-841-16
- 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 March 26, 2020
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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
- INDICATIONS & USAGE
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
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- Product Label
INGREDIENTS AND APPEARANCE
ACETAFLU NIGHTTIME EFFERVESCENT
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13411-841 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 10 mg Inactive Ingredients Ingredient Name Strength 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 Color white Score no score Shape ROUND (TABLET) Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13411-841-16 4 in 1 BOX 03/24/2020 1 4 in 1 BLISTER PACK; 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 03/24/2020 Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279) Establishment Name Address ID/FEI Business Operations S.P.M CORPORATION 555279715 manufacture(13411-841)