5a251962-305d-101b-e7fa-cb6b50c20a4f
5a251962-305d-101b-e7fa-cb6b50c20a4f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant
Description
(in each caplet) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg
Medication Information
Uses
- temporarily relieves these symptoms of the common cold:
- runny nose
- sneezing
- headache
- minor aches and pains
- nasal congestion
- cough
- sore throat
- temporarily reduces fever
Purpose
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Directions
- do not use more than directed (see overdose warning)
| adults and children 12 years and over |
take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours |
| children 6 to under 12 years of age |
take one caplet every 4 hours do not take more than 5 caplets in 24 hours |
| children under 6 years of age | do not use this product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage |
Other Information
- see end flap for expiration date and lot number
- store at controlled room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide
Description
(in each caplet) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg
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.
- with any other product containing diphenhydramine, even one used on 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 an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 12 caplets in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taking with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Product Packaging
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
CVS®
pharmacy
Compare to the active ingredients in
Sudafed PE® Severe Cold*
See New Warnings Information
SEVERE
COLD RELIEF PE
MULTI-SYMPTOM
ACETAMINOPHEN,
DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
PAIN RELIEVER/FEVER REDUCER, ANTIHISTAMINE
COUGH SUPPRESSANT, NASAL DECONGESTANT
● Nasal & Sinus Congestion
● Fever & Body Aches
● Cough & Sore Throat
Does not contain Pseudoephedrine
24 COATED CAPLETS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV1209B52608
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2010 CVS/pharmacy
1-800-shop-CVS
Active Ingredients
(in each caplet)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
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, condult a doctor promptly.
Questions Or Comments?
1-800-426-9391
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, cough or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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.
If Pregnant Or Breast Feeding,
ask a health professional before use.
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 Centrer right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Ask A Doctor Before Use If the User Has
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- a cough accompanied by too much phlegm (mucus)
- a persistant or chronic cough such as occurs with smoking, asthma, or emphysema
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If the User Is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Structured Label Content
Uses
- temporarily relieves these symptoms of the common cold:
- runny nose
- sneezing
- headache
- minor aches and pains
- nasal congestion
- cough
- sore throat
- temporarily reduces fever
Purpose
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Directions
- do not use more than directed (see overdose warning)
| adults and children 12 years and over |
take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours |
| children 6 to under 12 years of age |
take one caplet every 4 hours do not take more than 5 caplets in 24 hours |
| children under 6 years of age | do not use this product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage |
Other Information (Other information)
- see end flap for expiration date and lot number
- store at controlled room temperature 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)
corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide
Do Not Use (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.
- with any other product containing diphenhydramine, even one used on 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 an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Liver Warning: (Liver warning:)
This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 12 caplets in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taking with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Product Packaging (PRODUCT PACKAGING)
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
CVS®
pharmacy
Compare to the active ingredients in
Sudafed PE® Severe Cold*
See New Warnings Information
SEVERE
COLD RELIEF PE
MULTI-SYMPTOM
ACETAMINOPHEN,
DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
PAIN RELIEVER/FEVER REDUCER, ANTIHISTAMINE
COUGH SUPPRESSANT, NASAL DECONGESTANT
● Nasal & Sinus Congestion
● Fever & Body Aches
● Cough & Sore Throat
Does not contain Pseudoephedrine
24 COATED CAPLETS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV1209B52608
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2010 CVS/pharmacy
1-800-shop-CVS
Active Ingredients (Active ingredients)
(in each caplet)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Sore Throat Warning: (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, condult a doctor promptly.
Questions Or Comments? (Questions or comments?)
1-800-426-9391
When Using This Product (When using this product)
- do not exceed recommended dosage
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- nervousness, dizziness, or sleeplessness occur
- pain, cough or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
Keep Out of Reach of Children. (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 Centrer right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Ask A Doctor Before Use If the User Has (Ask a doctor before use if the user has)
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- a cough accompanied by too much phlegm (mucus)
- a persistant or chronic cough such as occurs with smoking, asthma, or emphysema
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If the User Is (Ask a doctor or pharmacist before use if the user is)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:07.896919 · Updated: 2026-03-14T22:52:28.188101