Label: DAYTIME SEVERE COLD AND COUGH- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder
- NDC Code(s): 73147-3110-6
- 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
Dextromethorphan hydrobromide 20 mg................................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 of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription and non-prescription). 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 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
- 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
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
DAYTIME SEVERE COLD AND COUGH
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73147-3110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM CITRATE (UNII: 1Q73Q2JULR) STARCH, CORN (UNII: O8232NY3SJ) RAW SUGAR (UNII: 8M707QY5GH) MENTHOL (UNII: L7T10EIP3A) Product Characteristics Color Score Shape Size Flavor BERRY (Berry Infused with Menthol and Green Tea flavors) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73147-3110-6 6 in 1 BOX, UNIT-DOSE; 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(73147-3110)