Label: HEAD CONGESTION COLD RELIEF- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Contains inactivated NDC Code(s)
NDC Code(s): 59779-473-01
- Packager: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 30, 2010
If you are a consumer or patient please visit this version.
- Drug Facts
- Active ingredients
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
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, ask a doctor or pharmacist before taking this product.
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 12 caplets in 24 hours
- children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Other information
- Inactive ingredients
- Questions or comments?
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Compare to the active
ingredients of Tylenol® Cold
Head Congestion Nighttime*
See New Warnings
PAIN RELIEVER, NASAL DECONGESTANT,
COUGH SUPPRESSANT, ANTIHISTAMINE
TO LET YOU SLEEP
CONTAINS 4 MEDICINES
Headache Pain -
Sore Throat -
Nasal Congestion - Phenylephrine HCl
Coughing - Dextromethorphan HBr
Runny Nose - Chlorpheniramine Maleate
12 COOL ICE® CAPLETS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2010 CVS/pharmacy
INGREDIENTS AND APPEARANCE
HEAD CONGESTION COLD RELIEF
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-473 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate 2 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 Starch, Corn (UNII: O8232NY3SJ) Fd&c Blue No. 1 (UNII: H3R47K3TBD) Fd&c Blue No. 2 (UNII: L06K8R7DQK) 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) Sucralose (UNII: 96K6UQ3ZD4) Talc (UNII: 7SEV7J4R1U) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 17mm Flavor MENTHOL (Cool Ice) Imprint Code 44;473 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-473-01 1 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 not final part343 07/21/2005 Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574) Registrant - L.N.K. International, Inc. (832867837) Establishment Name Address ID/FEI Business Operations L.N.K. International, Inc 832867894 MANUFACTURE