Label: COLD HEAD CONGESTION- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated
Contains inactivated NDC Code(s)
NDC Code(s): 54868-6233-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 24385-197
- 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 October 31, 2011
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- Active ingredient (in each caplet)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets 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
- 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
- trouble urinating due to an enlarged prostate gland
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
- Other information
- Inactive ingredients
- Questions or comments?
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Compare to active ingredients in Tylenol® Cold Head Congestion Daytime Caplets
Pain Reliever, Cough Suppressant, Nasal Decongestant
Contains 3 Medicines:
Headache/Sore Throat – Acetaminophen
Nasal Congestion – Phenylephrine HCl
Coughing – Dextromethorphan HBr
Cool Ice® Instant Cooling Sensation
Cold Head Congestion Package Label
INGREDIENTS AND APPEARANCE
COLD HEAD CONGESTION
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6233(NDC:24385-197) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CARNAUBA WAX (UNII: R12CBM0EIZ) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 17mm Flavor Imprint Code L402 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-6233-0 2 in 1 CARTON 1 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/16/2011 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel