Label: NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder
- NDC Code(s): 73147-3109-6
- Packager: Cellchem Pharmaceuticals Inc
- 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 January 11, 2021
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Active Ingredients (in each packet) Purpose
Acetaminophen 650 mg..................................................Pain reliever/Fever reducer
Diphenhydramine 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 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.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include
- skin reddening
- rash. If a skin reaction occurs, stop use and seek medical help right away.
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 children under 12 years
- if you are allergic to acetaminophen, phenylephrine or any other ingredient in this product
- with any other drug containing acetaminophen, phenylephrine. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on the skin
- 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 a 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
- 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
- a sodium restricted diet.
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 in 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
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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 for children even if you do not notice any signs or symptoms.
- do not use more than directed
- take every 4 hours, while symptoms persist.
Do not take more than 6 packets in 24 hours unless directed by a doctor.
adults and children 12 years and over
children under 12 years
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 a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
- INFORMATION FOR PATIENTS
- Inactive ingredients
- Questions, Comments or Adverse Reactions?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73147-3109 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 HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CARAMEL (UNII: T9D99G2B1R) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM CITRATE (UNII: 1Q73Q2JULR) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) Product Characteristics Color yellow Score Shape Size Flavor HONEY (honey lemon infused with Chamomile & white tea flavors) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73147-3109-6 6 in 1 CARTON; Type 0: Not a Combination Product 07/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2019 Labeler - Cellchem Pharmaceuticals Inc (111518618) Registrant - Cellchem Pharmaceuticals Inc (111518618) Establishment Name Address ID/FEI Business Operations Laboratoires Confab Inc 241754217 manufacture(73147-3109)