Label: ACETAFLU NIGHTTIME- acetaminophen, diphenhydramine hcl, phenylephrine hcl powder
- NDC Code(s): 13411-839-06
- 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 packet) Purposes
Acetaminophen 650 mg............................................................................Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg......................................................Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg............................................................Nasal decongestant
INDICATIONS & USAGE
• 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
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
DOSAGE & ADMINISTRATION
• 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
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
- INACTIVE INGREDIENT
- Product Label
INGREDIENTS AND APPEARANCE
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13411-839 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 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(13411-839)