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NDC 69842-0789-16 MAXIMUM STRENGTH COLD AND FLU 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 Details
MAXIMUM STRENGTH COLD AND FLU 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
MAXIMUM STRENGTH COLD AND FLU is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy, Inc. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 69842-0789-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 69842-0789-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 69842-0789-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
NDC | 69842-0789 |
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Product ID | 69842-789_c65be4e4-2653-5d9e-e053-2a95a90a16ee |
Associated GPIs | |
GCN Sequence Number | 074293 |
GCN Sequence Number Description | phenylephrine/DM/acetaminop/GG CAPSULE 5-325-200 ORAL |
HIC3 | B4P |
HIC3 Description | NON-OPIOID ANTITUSS-DECONGESTANT-ANALGESIC-EXPECT |
GCN | 38895 |
HICL Sequence Number | 035445 |
HICL Sequence Number Description | PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/ACETAMINOPHEN/GUAIFEN |
Brand/Generic | Generic |
Proprietary Name | MAXIMUM STRENGTH COLD AND FLU |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDE |
Product Type | HUMAN OTC DRUG |
Dosage Form | CAPSULE, LIQUID FILLED |
Route | ORAL |
Active Ingredient Strength | 325; 10; 200; 5 |
Active Ingredient Units | mg/1; mg/1; mg/1; mg/1 |
Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
Labeler Name | CVS Pharmacy, Inc |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 69842-0789-16 (69842078916)
NDC Package Code | 69842-789-16 |
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Billing NDC | 69842078916 |
Package | 1 BLISTER PACK in 1 CARTON (69842-789-16) / 8 BLISTER PACK in 1 BLISTER PACK / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
Marketing Start Date | 2021-07-10 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c0b36e4d-3667-58f6-e053-2a95a90afad7 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 softgels in 24 hrs, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- 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.
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash, or headache that lasts.
These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
Keep out of reach of children.
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH COLD AND FLU
acetaminophen,dextromethorphan hydrobromide,guaifenesin,phenylephrine hydrochloride capsule, liquid filled |
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Labeler - CVS Pharmacy, Inc (062312574) |
Registrant - TIME CAP LABORATORIES, INC. (037052099) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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MARKSANS PHARMA LIMITED | 925822975 | manufacture(69842-789) |